BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19372265 · Received May 22, 2024

    Report

    Report Number
    2249723-2024-02123
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    May 8, 2024
    Report Date
    September 25, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT). THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0202-00-0140 REV. K SN: (B)(6) SAFETY DISK. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ALL MANIFOLD TESTS FAILED(MEMBRANE DIFF. PRES.>6MMHG). PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED SAFETY DISK INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS AND THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. COULD NOT VERIFY THE FAILURE MESSAGE OF ALL MANIFOLD TESTS FAILED(MEMBRANE DIFF. PRE.>6MMHG). SAFETY DISK PASSED TESTING WITH RESULT OF MEMBRANE DIFF. PRE. 4MMHG, THE FACTORY SPECIFICATION IS +-6MMHG. RETAINING SAFETY DISK IN THE FAT DEPT. PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER (FSE) OBSERVED THE NEW SAFETY DISK, TESTS FAILED DURING THE ALL-MANIFOLD TESTS, HENCE DIDN'T REPLACE IT (MEMBRANE DIF PRS. >6MMHG). REINSTALLED ORIGINAL SAFETY DISK INTO THE UNIT AGAIN. ALL MANIFOLD TESTS, PASSED. EQUIPMENT OPERATED AS NORMAL. NEW SAFETY DISK REPLACEMENT WILL BE RESCHEDULED AGAIN AND FSE REPLACED COMPRESSOR, SCROLL, MUFFLER,1/8 NPT MUFFLER <100 MICRON AND O-RING, BUNA, AS PREVENTIVE MAINTENANCE (PM). IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETTING FIELD SERVICE ENGINEER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S NEW SAFETY DISK FAILED ALL MANIFOLD TESTS (MEMBRANE DIFF. PRS. >6MMHG). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769297 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown