BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURGE CASSETTE, STERILE, NON-QSK

    MDR report key: 24306022 · Received February 10, 2026

    Report

    Report Number
    1220648-2026-02781
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    February 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. PRIMARY UDI NUMBER IS UNKNOWN. D4. EXPIRATION DATE IS UNKNOWN. H4. DEVICE MANUFACTURE DATE IS UNKNOWN. DEVICE STATUS. 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

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. UPON REVIEW, IT WAS IDENTIFIED THAT THE IMPLANTATION DATE (D6A) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE DATE HAS NOW BEEN PROVIDED. UPON REVIEW, IT WAS IDENTIFIED THAT THE EXPLANTATION DATE (D6B) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE DATE HAS NOW BEEN PROVIDED. UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER CONTACT FAX NUMBER (G1) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. H6 INVESTIGATION TYPE CODE AND H6 COMPONENT CODE WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE PURGE CASSETTE DETECTION AND DIMENSION ISSUES WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED AND INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT DURING SET-UP OF AN IMPELLA DEVICE, AN ALARM OCCURRED FOLLOWING INSERTING A PURGE CASSETTE INTO THE DEVICE. IT WAS OBSERVED THAT THE CASSETTE APPEARED TO BE TOO SMALL FOR THE SPACE AND THAT THE CASSETTE DID NOT FIT WELL. THE PURGE CASSETTE WAS REPLACED AND THE REPLACEMENT CASSETTE RESOLVED THE ISSUE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116639 PURGE CASSETTE, STERILE, NON-QSK TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 LN 1944919

    Patients

    Seq Age Sex Outcome Treatment
    1