BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24054087 · Received January 13, 2026

    Report

    Report Number
    1220648-2026-00604
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 5, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 AND G1. THE IMPACTED PRODUCT WAS INITIALLY REPORTED AS THE CASSETTE; HOWEVER, UPON FURTHER REVIEW, THE EVENT OCCURRED ON THE PUMP AND HAS BEEN UPDATED ACCORDINGLY. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. THE CAUSE OF THE LOW PURGE PRESSURE COULD NOT BE DETERMINED SINCE PRODUCT WAS NOT RETURNED, DATA LOGS WERE NOT AVAILABLE, AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THEREFORE B5 AND H6 WAS UPDATED.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THE PURGE CASSETTE WAS DISCARDED AS WELL AS THE CP PUMP. THIS DID NOT RESOLVE THE FLUCTUATION IN PURGE PRESSURE. THE PATIENT WAS ESCALATED TO IMPELLA 5.5 SHORTLY AFTER PURGE ISSUE. ESCALATION WAS FOR MORE SUPPORT NOT DUE TO PURGE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED A PURGE PRESSURE FLUCTUATION AND A PURGE PRESSURE LOW ALARM. NO LEAKS WERE IDENTIFIED IN THE PURGE SYSTEM. THE PURGE CASSETTE WAS EXCHANGED WITHOUT RESOLUTION. IMPELLA SUPPORT CONTINUES, AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601279 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. PURGE CASSETTE GEN 2, STERILE, NON QSK 2026731065 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male