BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 8237580 · Received January 10, 2019

    Report

    Report Number
    2249723-2019-00069
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    November 30, 2018
    Report Date
    February 5, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS INITIATED ON A PATIENT FOR CORONARY PERFUSION DURING TRANSPORT TO ABQ FOR BYPASS. HOWEVER, ¿AUTOFILL FAILURE¿ OCCURRED ON THE IABP DURING USE WITH A 50CC SENSATION BALLOON. THE CUSTOMER STATED THAT ALL THE ON-SCREEN INSTRUCTIONS WERE FOLLOWED, BUT THIS DID NOT RESOLVE THE ISSUE; CUSTOMER THEN SWITCHED TO A 40CC BALLOON CATHETER AND THE IABP FUNCTIONED PROPERLY. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS IABP UNIT CANNOT BE REVIEWED PER THE SOP SINCE THE SERIAL NUMBER FOR THE UNIT WAS NOT PROVIDED. GETINGE SERVICE WAS NOT REQUESTED IN CONNECTION WITH THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS INITIATED ON A PATIENT FOR CORONARY PERFUSION DURING TRANSPORT TO ABQ FOR BYPASS. HOWEVER, ¿AUTOFILL FAILURE¿ OCCURRED ON THE IABP DURING USE WITH A 50CC SENSATION BALLOON. THE CUSTOMER STATED THAT ALL THE ON-SCREEN INSTRUCTIONS WERE FOLLOWED, BUT THIS DID NOT RESOLVE THE ISSUE; CUSTOMER THEN SWITCHED TO A 40CC BALLOON CATHETER AND THE IABP FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26807 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR