BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 22939069 · Received September 2, 2025

    Report

    Report Number
    1220648-2025-46087
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RETROGRADE PUMP FLOW/OPTICAL SENSOR ISSUE: CLINICAL REPORTED SENSOR FAILURE WHICH RESULTED IN RETROGRADE FLOW ALARM. NO IMC LOGS WERE PROVIDED. ANALYSIS OF LT AND RT LOGS REVEALED SUDDEN FLUCTUATIONS IN PLACEMENT SIGNALS, WITH PUMP FLOW OSCILLATING BETWEEN 0 AND 5 L/MIN THE LOGS CONFIRM ALARMS #1048 AND #1036 PLACEMENT SIGNAL NOT RELIABLE ALARMS. 5S PARAMETERS WERE RELATIVELY STABLE WITH PERIODICALLY LOW AND WIDESPREAD SNR VALUES WHILE PLACEMENT SIGNAL WENT OUT OF RANGE INTERMITTENTLY. FURTHER REVIEW OF LOGS FROM THE EXCHANGED AIC (IC12185) SHOWED THAT RETROGRADE FLOW (#426), PLACEMENT SIGNAL NOT RELIABLE (#1036), AND PLACEMENT SIGNAL NOT RELIABLE (#1048) ALARMS CONTINUED FOR TWO DAYS. THE CAUSE OF THE OPTICAL SIGNAL ISSUE WAS NOT ESTABLISHED AS NO CHARACTERIZED FAILURE PATTERNS WERE IDENTIFIED, LIMITED CLINICAL INFORMATION WAS PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE HISTORY LOT: DEVICE LOT NUMBER: 1932216. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    PRODUCT STATUS: THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, AN EVALUATION/ANALYSIS 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

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT TO BRIDGE TO HEART TRANSPLANT. IT WAS REPORTED ON THE 16TH DAY OF SUPPORT, THE IMPELLA HAD A SENSOR FAILURE WHICH THEN INITIATED AN ONGOING ¿PREVENTING RETROGRADE FLOW¿ ALARM. IT WAS NOTED THAT THE CALCULATIONS WERE NOT ACCURATE DUE TO THE OPTICAL SENSOR ISSUE. THE TEAM WAS INSTRUCTED TO MONITOR WITH DAILY ECHOCARDIOGRAMS AND TO MONITOR PURGE FLOW AND MOTOR CURRENT. SUPPORT WAS NOT AFFECTED BY THE SENSOR ISSUE. THE PATIENT REMAINED STABLE AND WAS SUCCESSFULLY BRIDGED TO HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346294 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026690254 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male