BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 13527304 · Received February 14, 2022

    Report

    Report Number
    2249723-2022-00293
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 20, 2022
    Report Date
    March 1, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION NOT YET DETERMINED: ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE REPAIR AND STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BLOOD RUPTURE. CUSTOMER REPORTS BLOOD BACK. THERE WAS NO ADVERSE EVENT REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) DID A THOROUGH INVESTIGATION AND ASSESSMENT ON SITE. FOUND SEVERAL PARTS CONTAMINATED WITH BLOOD AND ORDERED. REPLACED PNEUMATIC MODULE (D997-00-1178), PNEUMATIC INTERFACE (D670-00-1167 ), PRINTER (D161-00-0024-04), CABLE ASSEMBLY TO BACKPLANE (D012-00-1640), 300 PSI VALVE (D103-00-0634), PNEUMATIC FITTING (D103-00-0658-02), RELIEF VALVE (D103-17-0004) AND PRESSURE TRANSDUCER(D682-00-0092-02), HELIUM FILL MANIFOLD ASSY (D104-00-0014), SCREW KIT (D104-00-0014) . A FULL CALIBRATION AND FUNCTIONAL CHECK HAS BEEN PERFORMED PER THE FACTORY CALIBRATION PROCEDURES. RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BLOOD BACK. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669066 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown