BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 15382755 · Received September 8, 2022

    Report

    Report Number
    2249723-2022-02286
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Report Date
    March 17, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN ORDER TO FIX THE ISSUE A GETINGE FSE REPLACED THE FOLLOWING INTERNAL ASSEMBLIES THAT WERE EXPOSED TO LIQUIDS: PNEUMATIC MODULE ASSY (0997-00-1178), POWER MANAGEMENT PCBA (0670-00-1162), MOTOR CONTROL PCB (0670-00-1159), SOLENOID CONTROL PCB (0670-00-1161), BACKPLANE PCB (0670-00-1163), THERMAL PRINTER (0161-00-0024-04), PCBA PWR SLOT INTERFACE (0997-00-1169E), FIBER OPTIC ASSY (0997-00-1169E), AND PNEU MOD TO BACKPLANE CABLE (0012-00-1708). THE FSE THEN COMPLETED A FULL PREVENTIVE MAINTENANCE (PM), THE UNIT PASSED ALL TESTS TO FACTORY SPECIFICATIONS. THE UNIT WAS THEN RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS : G7,H2,H10,H11 CORRECTED SECTIONS : B5.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. THE DEVICE WAS USED ON THE DECEASED PATIENT TO CIRCULATE THE BLOOD FOR ORGAN DONATION, WHICH DID NOT RESULT IN PATIENT HARM OR ADVERSE EFFECTS. THE REPORTABLE EVENT TYPE (H1) AND HEALTH EFFECT CLINICAL CODE AND IMPACT CODE (H6) HAS BEEN CAPTURED AS A MALFUNCTION AND NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BLOOD BACK EVENT. THE CUSTOMER INDICATED THAT THE IABP WAS BEING USED TO KEEP BLOOD MOVING ON A DECEASED PATIENT IN ORDER TO HARVEST DONATED ORGANS. THE IAB WAS RUPTURED IN THE PROCESS OF HARVESTING AND BLOOD ENTERED INTO THE IABP. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BLOOD BACK EVENT. THE CUSTOMER INDICATED THAT THE IABP WAS BEING USED TO KEEP BLOOD MOVING ON A DECEASED PATIENT IN ORDER TO HARVEST DONATED ORGANS. THE IAB WAS RUPTURED IN THE PROCESS OF HARVESTING AND BLOOD ENTERED INTO THE IABP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234714 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IAB CATHETER