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Date: May 21, 2025
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CREDICORP LTD.
(Registrant)
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By:
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/s/ Guillermo Morales
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Guillermo Morales
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Authorized Representative
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Reference:
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a) Official Letter No. 2302-2025-SMV/11.1
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b) File No. 2025017716
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1. |
Question No. 1: Explain why your company has not yet disclosed, as a material event, all documentation
related to the events at SANNA Clínica San Borja and SANNA Clínica Sánchez Ferrer.
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2. |
Question No. 2: Disclose all information related to the administration of defective saline solution to
various patients in the SANNA Clinic Network.
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Remove from the clinic’s storage areas all 0.9% saline solution in 1000cc presentation for intravenous infusion from any Medifarma batch and quarantine them in the product review area.
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Replace Medifarma saline solution being administered to patients with another brand.
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Report on the four suspected adverse drug reactions to DIGEMID via the Vigiflow system.
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Notify Medifarma of the incidents and request a review of their quality control for the affected batch.
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Conduct random sampling and analysis of Medifarma’s 0.9% saline bottles from various batches in circulation between March 18 and 21.
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SANNA Clínica Sánchez Ferrer received
1,008 bottles of the defective saline solution batch 2123624 from Medifarma on February 10, 2025. As of March 21, 2025, only five (5) bottles remained available, of which three (3) were sent to the company Hypatia S.A. on March 25, 2025,
for the corresponding analysis. The remaining two (2) bottles were handed over to the Public Prosecutor’s Office and GERESA.
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During this period, two patients were identified who, among other diagnoses, developed severe hypernatremia during their hospitalizations. These cases were attributed to causes other than sodium overload from defective saline, given that
multiple patients simultaneously received saline solution from the same batch without presenting any symptoms or signs associated with that diagnosis during their medical care.
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The first case involved a 72-year-old female patient with multiple chronic conditions under appropriate treatment and control. She was admitted on February 20, 2025, due to an acute condition that required intravenous hydration as part
of her treatment. During her hospitalization, she developed a case of severe hypernatremia (196 mmol/L) and was transferred to the ICU. Despite the efforts made by the multidisciplinary team in managing the diagnosis, the patient’s
condition deteriorated, and she unfortunately passed away on February 28, 2025.
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The second case involved a 91-year-old male patient with multiple comorbidities, who was chronically bedridden and had a history of several previous hospitalizations. He was admitted on March 4, 2025, due to an acute abdominal surgical
condition. He underwent emergency surgery and was transferred to the ICU for multidisciplinary management. From the time of admission, he received intravenous hydration with saline solution. On March 6, 2025, he developed severe
hypernatremia (197 mmol/L). Despite medical care, his condition deteriorated, and he unfortunately passed away on March 11, 2025.
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1. |
Contacted the families of patients affected by the defective saline to inform them of the events and the patients’ conditions.
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2. |
Psychological support was offered to the families of the patients affected by Medifarma’s saline solution, and the waiver and reimbursement of the patients’ medical expenses were communicated.
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3. |
For non-critical patients affected by Medifarma’s defective saline, each clinic conducted daily symptom monitoring and provided free medical care and tests. To date, all of these patients have been discharged.
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4. |
Finally, active cooperation was provided to administrative and criminal authorities by supplying all the information required within the framework of the corresponding investigations.
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3. |
Question No. 3: Confirm and/or clarify all information about the legal proceedings initiated by MINSA
against the SANNA Clinic Network.
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(i) |
A first criminal investigation, related to the Administration of Saline Solution at SANNA Clínica Sánchez Ferrer, was initiated by the First Provincial Corporate Criminal Prosecutor’s Office of
Trujillo and later transferred to the Second Provincial Corporate Criminal Prosecutor’s Office of Santa Anita, in the Lima East District. A jurisdictional dispute is currently pending resolution to determine which prosecutor’s office is
competent to handle the investigation.
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(ii) |
The other two criminal investigations are related to the Administration of Saline Solution at SANNA Clínica San Borja and were initiated by the Office of the Attorney General of the Ministry of
Health or by relatives of affected patients. These investigations are in the preliminary stage and are being handled by the Third Office of the Second Provincial Criminal Prosecutor’s Office of Santa Anita and the Third Office of the Second
Criminal Prosecutor’s Office of Miraflores, Surquillo, and San Borja.
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4. |
Question No. 4: Report whether any administrative proceedings have been initiated by Peruvian State
authorities against any of the clinics within the SANNA Clinic Network, which are part of your economic group, or against their respective officials
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5. |
Question No. 5: Provide detailed information on all decisions made by the governing bodies of your company or
of the companies within your economic group in relation to the serious events mentioned. If no decisions have been made, please report this situation and indicate the reasons.
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6. |
Question No. 6: Report everything related to the economic/financial impact caused by the aforementioned
events and their consequences on your organization and/or the companies within your economic group, as well as the measurement of such impact to date.
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7. |
Question No. 7: Indicate all information related to the measurement of reputational impact on your company
and the companies within your economic group.
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8. |
Question No. 8: Provide any additional relevant information
regarding the matters addressed in this Letter.
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