BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 11591288 · Received March 30, 2021

    Report

    Report Number
    2249723-2021-00673
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 29, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    HISTORICAL DATA ANALYSIS: (4109/646) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME SERIAL NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/646) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (MAR 2019 THROUGH FEB 2021) WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. ANALYSIS OF PRODUCTION: (3331/646) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED SERIAL NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 1

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO INVESTIGATE THE REPORTED ISSUE AND THE STM CONFIRMED THE PROBLEM UPON ARRIVAL TO THE SITE. THE STM REPORTED THAT THE DEVICE POWER SUPPLY HAD BEEN TAPED TO THE FLOOR AND IT WAS DIRTY & STICKY. POWER CORD WAS CLEANED AND DEVICE OPERATED AS NORMAL. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE POWER CORD IN THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS STUCK AND ONLY HAD ABOUT 12¿ OF LENGTH. THE CUSTOMER HAD TRIED AN EXTENSION CORD BUT THE UNIT WOULD NOT CHARGE. THERE WAS 30 MINUTES OF PUMP TIME LEFT ON BATTERY POWER AT THE TIME OF THE CALL. THE CUSTOMER OBTAINED ANOTHER CARDIOSAVE FROM THE CCL AND SWITCHED OVER TO CONTINUE WITH THE THERAPY. THERE WAS MINIMAL DOWNTIME OF THERAPY (APPROXIMATELY 60 SECONDS). THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488334 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 62 YR