BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 371 14F LT CMR SET

    MDR report key: 24120612 · Received January 20, 2026

    Report

    Report Number
    1220648-2026-01169
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 18, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    813502011876
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: CP PUMP, SN: (B)(6), PC & DATA STICK WERE RETURNED. TEMPORARY PUMP STOP: CLINICAL DETAILS NOTED THAT WHEN WEANING PUMP AT P-3, A "IMPELLA STOPPED" ALARM OCCURRED. PUMP WAS ABLE TO BE RESTARTED AT P-2 AND WAS THEN EXPLANTED. DATA LOGS WERE REVIEWED AND RT AT TIME OF PUMP STOP SHOWS A FIRST MOTOR CURRENT SPIKE TO 1000 WITH A ALARM #13 PUMPS STOP. PUMP FLOWS WERE MOMENTARILY SATURATED BEFORE STOPPING. PUMP WAS ABLE TO BE RESTARTED FOR APPROXIMATELY 1 MINUTES BEFORE A SECOND MOTOR CURRENT SPIKE TO APPROXIMATELY 1500 AND SUBSEQUENT PUMP STOP. RETURNED PUMP WAS VISUALLY INSPECTED AND SHOWED NO SIGNED OF DAMAGE. PUMP WAS ABLE TO BE CONNECTED TO CONSOLE AND RUN IN THE LAB WITHOUT A PUMP STOP FOR APPROXIMATELY 45 MINUTES. THE CAUSE OF THE PUMP STOP COULD NOT BE DETERMINED AS ISSUE WAS NOT REPRODUCED WITH RETURNED PRODUCT AND LIMITED CLINICAL DETAILS WERE PROVIDED. HIGH PURGE PRESSURE: CLINICAL DETAILS NOTED THAT JUST PRIOR TO PUMP STOP, A "PURGE PRESSURE HIGH" ALARM WAS OBSERVED BY CLINICAL STAFF AND IMMEDIATELY RESOLVED ON ITS OWN. DATA LOGS WERE REVIEWED AND NO "HIGH PURGE PRESSURE" ALARMS WERE NOTED IN LOGS. PURGE PRESSURE AND PURGE FLOW VALUES WERE STABLE AT TIME OF REPORTED ISSUE. RETURNED PUMP DID NOT HAVE ANY BIOMATERIAL AROUND PURGE GAP, AND WAS ABLE TO PURGE AND RUN WITHOUT ISSUE FOR APPROXIMATELY 45 MINUTES. NO DEFECT WAS FOUND WITH THE PUMP IN RELATION TO HIGH PURGE PRESSURE DURING THE CASE BASED RETURNED PRODUCT AND DATA LOG ANALYSIS. DEVICE HISTORY LOT: DEVICE LOT: 1970210. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: PUMP SN: (B)(6) PASSED ALL POST-STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    DEVICE STATUS. THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION/ANALYSIS IS UNDERWAY. UPON COMPLETION OF THE ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED PUMP ALARMS FOR A PUMP STOP AND HIGH PURGE PRESSURE. IT WAS REPORTED THAT DURING SUPPORT AND WHILE WEANING THE PATIENT FROM THE DEVICE, THE IMPELLA CP ALARMED FOR HIGH PURGE PRESSURE. THE ALARM SELF-RESOLVED AND SUBSEQUENT TO THE HIGH PURGE PRESSURE ALARM, THE IMPELLA CP ABRUPTLY STOPPED PUMPING. THE IMPELLA WAS RESTARTED BY THE PATIENT¿S NURSE FOLLOWING VERBAL DIRECTIONS BY AN ABIOMED CLINICAL CONSULTANT. THE IMPELLA WAS RESTARTED, AND THE DEVICE CONTINUED TO BE WEANED AND REMOVED WITHIN FIVE MINUTES OF THE PUMP STOP OCCURRING. NO SIGNS OR SYMPTOMS OF PATIENT INJURY WERE REPORTED, THERE WAS NO REPORTED HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188067 PUMP 371 14F LT CMR SET TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026740471 813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male