BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3871943 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00461
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE FOUND AN INCORRECT LUER PLUG USED TO PLUG THE SAFETY DISK CAUSING THE DISK TO LEAK AND FAIL. THE COMPANY REPRESENTATIVE: REPLACED THE INCORRECT LUER PLUG WITH THE CORRECT LUER PLUG, TESTED PUMP PERFORMANCE TO FACTORY SPECIFICATIONS; SAFETY TESTED AND GAVE AN IN SERVICE TO THE CUSTOMER ON HOW TO PERFORM THE SAFETY DISK LEAK TEST. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE IABP FAILED THE SAFETY DISK LEAK TEST. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235911 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1