BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA CP

    MDR report key: 23618887 · Received November 21, 2025

    Report

    Report Number
    1220648-2025-48549
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    August 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    04260113630280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ACCORDING TO THE CLINICAL DETAILS, A PURGE LEAK WAS REPORTED ON 22-AUG AND THE ISSUE WAS RESOLVED. A SECOND PURGE LEAK WAS REPORTED ON 24-AUG, AND THE PRODUCT WAS SENT FOR INVESTIGATION. DATA LOG REVIEW WAS NOT REQUIRED FOR THIS CASE RUN. PURGE LEAK ¿ PUMP: THE PUMP AND PURGE CASSETTE WERE INVESTIGATED, AND NO ISSUE WAS FOUND RELATED TO THE PURGE CASSETTE. DAMAGE WAS IDENTIFIED ON THE PUMP SIDEARM, WITH A LENGTHWISE CRACK DOWN THE YELLOW LUER, WHERE THE PURGE LEAK WAS REPRODUCED. THE CAUSE OF THE PURGE LEAK WAS A CRACK IN THE YELLOW LUER BUT THE CAUSE OF THE CRACK WAS UNABLE TO BE DETERMINED. THE SUPPLIER INVETIGATION OF SIMILAR COMPLAINT INDICATED POSSIBLE HIGH TENSION IN COMBINATION WITH DISINFECTANTS AND CERTAIN DRUG INGREDIENTS LIKE FOR EXAMPLE OIL, ALCOHOL, LIPIDS BUT WAS UNABLE TO CONFIRM. DEVICE HISTORY LOT: DEVICE BATCH: 1940910. DEVICE HISTORY REVIEW: THE PUMP (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. DURING THE FIRST DAY OF SUPPORT, IT WAS REPORTED THAT THE PURGE SYSTEM WAS LEAKING. THE PURGE CASSETTE WAS REPLACED, AND THE NURSE REPORTED THAT THIS RESOLVED THE ISSUE. HOWEVER, THE FOLLOWING DAY IT WAS AGAIN REPORTED THE PURGE SYSTEM WAS LEAKING. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE PUMP AND THE SECOND CASSETTE WERE SENT FOR INVESTIGATION FOR THE PURGE LEAK. ON (B)(6) 2025, INVESTIGATION FINDINGS REVEALED THAT THE PURGE LEAK ISSUE WAS DUE TO THE DAMAGED SIDEARM PORTION OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227763 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026693227 04260113630280

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male