BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24278463 · Received February 6, 2026

    Report

    Report Number
    1220648-2026-02450
    Event Type
    Death
    Date Received
    February 6, 2026
    Date of Event
    December 3, 2025
    Report Date
    March 2, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: B5 NARRATIVE UPDATED.

    Additional Manufacturer Narrative · 0

    CORRECTED: D4 (SERIAL). PPAE ( ORGAN FAILURE/SEPSIS/CARDIAC ARREST): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: ADDED CODE F2303.

    Description of Event or Problem · 0

    A 68 -YEAR-OLD MALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK UNDER CARDIOPULMONARY RESUSCITATION WITH A LEFT VENTRICULAR EJECTION FRACTION OF 15 % AND A LACTATE OF 3.0 MMOL/L WITH A MEAN ATRIAL PRESSURE OF 44 MMHG UNDER 1 INOTROPE AND RESPIRATORY SUPPORT WITH OXYGEN SATURATION OF 58% IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. HE HAD A KNOWN HISTORY OF CORONARY ARTERY DISEASE (LEFT VENTRICULAR EJECTION FRACTION OF 15%) AND CHRONIC KIDNEY DISEASE OF STAGE 3. IMPELLA CP WAS PLACED WITH ULTRASOUND-GUIDED MICRO-PUNCTURE VIA THE RIGHT FEMORAL ARTERY WITHOUT A PERCUTANEOUS CORONARY INTERVENTION PERFORMED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. URINE OUTPUT DECREASED TO 20CC/HOUR. UPON ON ARRIVAL ON THE INTENSIVE CARE UNIT, HOWEVER, PATIENT DECOMPENSATED AND HAD TO BE INTUBATED. (THE FIELD REPRESENTATIVE RELAYED THAT THE PATIENT HAD LABS DRAWN TO CONFIRM SUSPICION OF SEPSIS AND URINE SAMPLES TAKEN THE PATIENT WAS STARTED ON ANTIBIOTICS). SOME HOURS LATER, THE PATIENT FURTHER DECLINED. EVENTUALLY, PATIENT WENT INTO VENTRICULAR FIBRILLATION AND HAD A CARDIAC ARREST AND EXPIRED ON IMPELLA CP SUPPORT. DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA CP WHILE MOST LIKELY TO BE CAUSED BY THE UNDERLYING DISEASE.

    Description of Event or Problem · 0

    A 68 -YEAR-OLD MALE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ACUTE MYOCARDIAL INFARCTION CARDIOGENIC SHOCK UNDER CARDIOPULMONARY RESUSCITATION WITH A LEFT VENTRICULAR EJECTION FRACTION OF 15 % AND A LACTATE OF 3.0 MMOL/L WITH A MEAN ATRIAL PRESSURE OF 44 MMHG UNDER 1 INOTROPE AND RESPIRATORY SUPPORT WITH OXYGEN SATURATION OF 58% IN SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS SHOCK STAGE E. HE HAD A KNOWN HISTORY OF CORONARY ARTERY DISEASE (LEFT VENTRICULAR EJECTION FRACTION OF 15%) AND CHRONIC KIDNEY DISEASE OF STAGE 3. IMPELLA CP WAS PLACED WITH ULTRASOUND-GUIDED MICRO-PUNCTURE VIA THE RIGHT FEMORAL ARTERY WITHOUT A PERCUTANEOUS CORONARY INTERVENTION PERFORMED AND TRANSFERRED TO THE INTENSIVE CARE UNIT. URINE OUTPUT DECREASED TO 20CC/HOUR. UPON ON ARRIVAL ON THE INTENSIVE CARE UNIT, HOWEVER, PATIENT DECOMPENSATED DUE TO SEPTIC SHOCK AND HAD TO BE INTUBATED. SOME HOURS LATER, THE PATIENT FURTHER DECLINED. EVENTUALLY, PATIENT WENT INTO VENTRICULAR FIBRILLATION AND HAD A CARDIAC ARREST AND FINALLY EXPIRED ON IMPELLA CP SUPPORT. DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA CP WHILE MOST LIKELY TO BE CAUSED BY THE UNDERLYING DISEASE AND UNRELATED TO IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298932 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026758519 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1