BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24661121 · Received March 23, 2026

    Report

    Report Number
    1220648-2026-05788
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    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

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E1 (ZIP CODE EXTENSION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN E3 (INITIAL REPORTER OCCUPATION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY SUBMITTED IN ERROR IN THE INITIAL REPORT. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE FLUID LEAK FROM THE SIDE ARM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN. THE CAUSE OF THE PRODUCT DAMAGE OF THE PURGE SYSTEM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND CONFIRMED THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS. THE CAUSE OF THE FLUID LEAK FROM THE SIDE ARM AND PRODUCT DAMAGE OF THE PURGE SYSTEM WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN. H6 COMPONENT CODING AND INVESTIGATION TYPE, FINDINGS AND CONCLUSION CODING HAVE BEEN UPDATED BASED ON THE COMPLETED INVESTIGATION. CORRECTION. D4 UNIQUE DEVICE IDENTIFER WAS UPDATED, CORRECTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4 SERIAL NUMBER UPDATED/CORRECTED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT THE REGISTERED NURSE ATTEMPTED CASSETTE CHANGE AND THEN CALLED WITH BROKEN SIDE ARM; BROKEN BETWEEN FILTER AND PURGE RESERVOIR. PERFORMED PURGE BYPASS. THERE WAS NO HARM TO THE PATIENT AND THE COMPLAINT PROCEDURE OUTCOME WAS SUCCESSFUL WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250482 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026774557 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1