BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16060391 · Received December 28, 2022

    Report

    Report Number
    2249723-2022-03352
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    May 3, 2021
    Report Date
    November 21, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. THE FSE BEGAN THE REPAIRS ON MAY 6, 2021. THE FOLLOWING PARTS WERE REPLACED: 0012-00-1708 CABLE, PNEUMATICS INTERFACE TO BACKPLANE. 0997-00-1178 PNEUMATIC INTERFACE MODULE ASSEMBLY. 0670-00-1162 PCBA, POWER MANAGEMENT. 0012-00-1640 CABLE ASSEMBLY, PM TO BACKPLANE. 0012-00-1675 CABLE, POWER ON SWITCH AND LED. 0012-00-1564-01 CABLE ASSEMBLY, FAN, 70MM 6¿. 0012-00-1705 CABLE, POWER PACK STATUS LEDS. 0670-00-1168 PCBA, PRINTER INTERFACE. 0161-00-0024-04 PRINTER, THERMAL, XE-50B, CUSTOM. 0670-00-1167 PCBA, PNEUMATICS INTERFACE. 0441-00-0191 CHASSIS, PNEUMATIC ASSEMBLY. AFTER THE REPLACEMENT OF PARTS, CLEANING AND STERILIZATION WERE PERFORMED. PREVENTIVE MAINTENANCE INCLUDING SYSTEM FUNCTIONAL CHECK, RUNNING TEST, AND ELECTRICAL SAFETY TEST WERE PERFORMED NORMALLY. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    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 ISSUE DUE TO AN INTRA-AORTIC BALLOON RUPTURE. NO PATIENT HARM WAS REPORTED. THIS IS RELATED TO IAB COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470984 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