BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24480129 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04286
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    October 14, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    A 65 YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY THAT INCLUDES DIABETES MELLITUS, HIGH BLOOD PRESSURE, AND HIGH CHOLESTEROL PRESENTED WITH A SUDDEN ONSET OF CHEST PAIN AND SHORTNESS OF BREATH. HE WAS DIAGNOSED WITH A ST ELEVATION MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE MEDICAL TEAM MADE THE DECISION TO IMPLANT AN IMPELLA CARDIAC POWER (CP) HEART PUMP DEVICE. THE IMPELLA CP DEVICE WAS SUCCESSFULLY IMPLANTED, AND A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WAS PERFORMED. DUE TO THE NEED FOR A HIGHER LEVEL OF HEART PUMP SUPPORT, THE TEAM DECIDED TO ESCALATE SUPPORT TO THE IMPELLA 5.5 DEVICE. THE IMPELLA FIVE POINT FIVE DEVICE WAS IMPLANTED AND THE IMPELLA CP DEVICE WAS EXPLANTED WITHOUT COMPLICATION. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT, WHERE IT WAS LATER DECIDED THAT HE SHOULD BE TRANSFERRED TO A TERTIARY MEDICAL CENTER FOR A HIGHER LEVEL OF CARE. DURING AIR TRANSPORT, THE PATIENT HAD UNSTABLE BLOOD PRESSURE. UPON ARRIVAL, THE IMPELLA 5.5 INSERTION SITE WAS NOTED TO BE OOZING BLOOD, AND THE PRESSURE DRESSING WAS SATURATED. ON THE FOLLOWING DAY, DIURESIS WAS INITIATED. ON THE THIRD DAY AFTER TRANSFER, THE PATIENT¿S LABORATORY VALUES, INCLUDING LACTATE DEHYDROGENASE, PLASMA FREE HEMOGLOBIN, AND ALANINE AMINOTRANSFERASE, SHOWED IMPROVEMENT. ON THE FOURTH DAY, THE PATIENT WAS REPORTED TO COUGH UP BLOOD. THE EAR, NOSE, AND THROAT MEDICAL TEAM EVALUATED THE PATIENT, AND A BRONCHOSCOPY WAS PERFORMED, WHICH REVEALED NO ACTIVE BLEEDING. ACCORDING TO THE CARDIOTHORACIC INTENSIVE CARE UNIT TEAM, THE MOST LIKELY CAUSE WAS IRRITATION OF THE UPPER AIRWAY. ON THE SIXTH DAY, THE PATIENT WAS SUCCESSFULLY WEANED FROM SUPPORT, AND THE IMPELLA 5.5 DEVICE WAS REMOVED WITHOUT ISSUES. WHILE THE IMPELLA 5.5 PUMP IS CONSERVATIVELY CODED FOR THE COMPLICATIONS, THEY ARE MORE LIKELY DUE TO PUMP MALPOSITIONING AND THE REPORTED HEMOPTYSIS WAS MORE LIKELY DUE TO UPPER RESPIRATORY IRRITATION. THE PUMPS FUNCTIONED AS INTENDED, AND NO DEVICE MALFUNCTION WAS REPORTED. DURING IMPELLA 5.5 SUPPORT, STERILE SLEEVE WAS SEPARATED FROM LOCKING MECHANISM DURING REPOSITIONING. PUMP POSITION REMAINED STABLE AND A SMALL TEGADERM WAS USED TO RE-SECURE SLEEVE. SLEEVE WAS KEPT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541726 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026679925 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention