BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24158483 · Received January 23, 2026

    Report

    Report Number
    1220648-2026-01365
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    December 3, 2025
    Report Date
    January 28, 2026
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: HEMATURIA: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. PLACEMENT SIGNAL ISSUE: CLINICAL REPORTED PLACEMENT SIGNAL LOW ALARMS. THE DATA LOGS CONFIRM ALARMS. RIGHT BEFORE ALARM OCCURRENCE, THERE WAS A SPIKE IN PLACEMENT SIGNAL WITH SUDDEN DECREASE IN SNR AND A VARIATION IN CONTRAST. THERE WAS ALSO A SLIGHT DECREASE IN PURGE FLOW AND AN INCREASE IN PUMP FLOW WITH NO P-LEVEL CHANGE AT THIS INSTANT. PUMP WAS SET TO P-8. THERE WERE 2 BRIEF SUCTION EVENTS LASTING LESS THAN 3 MINUTES DURING PLACEMENT SIGNAL LOW EVENT. OTHER 5S PARAMETERS REMAINED STABLE. RT LOG ANALYSIS SHOWED PERIODIC DIPS IN PLACEMENT SIGNAL BELOW TRIGGER THRESHOLD OF 30MMHG. LOW SNR REMAINED FOR ABOUT 7 HOURS BEFORE RECOVERING TO PREVIOUS VALUES. NO CHARACTERIZED PUMP FAILURE PATTERNS WERE OBSERVED. THERE WERE NO POSITION RELATED ALARMS. LIMITED CLINICAL INFORMATION WAS PROVIDED ON PATIENT CONDITION OR CLINICAL EVENTS DURING ALARMS. THE CAUSE OF THE ISSUE WAS NOT ESTABLISHED AS LIMITED CLINICAL INFORMATION WAS PROVIDED AND NO PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE HISTORY LOT: DEVICE LOT : 1920394. DEVICE HISTORY BATCH: SUBCOMPONENT LOT : N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    B1 PRODUCT PROBLEM, B5 CLINICAL RATIONALE, D4 UDI INFORMATION AND H6 HEALTH EFFECT - CLINICAL CODE E0303, WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT.

    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

    CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). UPON REVIEW, THE SECTION D CATALOG NUMBER HAS NOW BEEN CORRECTED.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA RIGHT FEMORAL ARTERY IN A 54 YEAR OLD MALE FOR ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SCAI SHOCK STAGE E. THE PATIENT WAS IN THE ICU ON SUPPORT WITH THE CP. ON DAY 3 OF SUPPORT, HEMATURIA WAS REPORTED. URINARY OUTPUT WAS GREATER THAN 30 CC/HR AND NOTED TO BE CONCENTRATED/AMBER. THERE HAD BEEN PURGE SYSTEM LOW ALARMS OVERNIGHT. THE DEVICE WAS EXPLANTED. HEMOLYSIS IS A KNOWN RISK ASSOCIATED WITH IMPELLA CP AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS TRANSFERRED FROM ANOTHER FACILITY WHILE SUPPORTED WITH A PERCUTANEOUS MECHANICAL CIRCULATORY SUPPORT DEVICE. THE TRANSPORT WAS UNEVENTFUL, AND UPON ARRIVAL THE PATIENT WAS MOVED TO THE BED WITHOUT INCIDENT. ALL DEVICE WAVEFORMS APPEARED APPROPRIATE, FLOWS WERE NORMAL, AND NO ACTIVE ALARMS WERE PRESENT. DURING THE TRANSITION OF THE CONSOLE CONNECTIONS, THE ARTERIAL INLET CABLE WAS DISCONNECTED AND RECONNECTED, FOLLOWED BY THE PURGE CASSETTE. WHEN THE NURSE ATTEMPTED TO DISCONNECT THE ARTERIAL INLET CABLE BY TWISTING IT, SHE WAS INSTRUCTED TO PULL IT STRAIGHT OUT. AFTER RECONNECTION, THE PUMP WAS RESTARTED; HOWEVER, SUCTION EVENTS OCCURRED AND THE WAVEFORMS RESEMBLED ELECTRICAL INTERFERENCE. THE NURSE WAS INSTRUCTED TO ENSURE THE ARTERIAL INLET CABLE WAS FULLY SEATED, WHICH IT WAS. THE CLINICAL SUPPORT CENTER WAS CONTACTED AND ADVISED DISCONNECTING AND RECONNECTING THE CABLE AGAIN, BUT THIS DID NOT CORRECT THE ISSUE. DEVICE POSITION WAS VERIFIED BY ECHOCARDIOGRAPHY. THE PUMP WAS INCREASED TO PERFORMANCE LEVEL SIX IN AN ATTEMPT TO RESOLVE THE SUCTION. APPROXIMATELY ONE HOUR AFTER THE CABLE TRANSITION, THE WAVEFORMS RETURNED TO NORMAL AND SUCTION EVENTS RESOLVED, INCLUDING AT HIGHER FLOW SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219829 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 PUMP 381 PUMP SET (US) 2026661308 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention