BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 2894505 · Received May 15, 2008

    Report

    Report Number
    2531527-2008-00005
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    February 12, 2008
    Report Date
    May 12, 2008
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PUMP INVOLVED IN THE INCIDENT WAS RETURNED FOR EVAL. ALSO INCLUDED WAS THE INFUSION ASSEMBLY THAT WAS REPORTEDLY IN USE AT THE TIME OF THE INCIDENT. AN EVAL OF THE PUMP WAS CONDUCTED UPON RECEIPT WHICH CONFIRMED THAT THE PUMP WAS FUNCTIONAL AND MET THE PERFORMANCE REQUIREMENTS. NO DAMAGE OR DEFECTS WERE NOTED ON THE PUMP, EXCEPT FOR THE MODIFICATION TO THE PUMP INFUSION LINE THAT WAS PERFORMED BY THE CUSTOMER. INTERNAL ANALYSIS OF THE PUMP FOUND NO ABNORMAL WEAR OR DAMAGE. NO AIR LEAKS OR DAMAGE WERE NOTED ON THE PUMP INFUSION LINE OR LUER FITTING. A PRESSURE TEST OF THE INFUSION ASSEMBLY FOUND A LEAK AT THE DRIP CHAMBER, BUT NO DAMAGE OR LEAKS IN THE VICINITY OF TE BACTERIOLOGIC FILTER AS WAS REPORTED BY THE CUSTOMER. THE CAUSE OF AIR ENTRY INTO THE PUMP INFUSION LINE COULD NOT BE ESTABLISHED FROM THE ANALYSIS OF THE PUMP OR INFUSION ASSEMBLY.

    Description of Event or Problem · 1

    AFTER APPROX 5 DAYS OF USE, AN INFUSION AIR BUBBLE ALARM OCCURRED ON THE CONTROLLER. SMALL AIR BUBBLES WERE OBSERVED ENTERING THE INFUSION ASSEMBLY AT THE BACTERIOLOGIC FILTER AND MIGRATING TOWARD THE PUMP. THE CLINICIANS ALSO REPORTED THAT A LOW FLOW ALARM OCCURRED ON THE CONTROLLER AND THE PUMP WAS OBSERVED TO BE CHATTERING. THE LOW FLOW ALARM WAS RESOLVED BY REORIENTING THE PT, REDUCING THE PUMP SPEED, AND ADDING VOLUME TO CORRECT PT FILLING ISSUES. THE CLINICIANS CLAMPED THE INFUSION LINE TO PREVENT FURTHER AIR MIGRATION IN THE INFUSION LINE AND CHANGED THE INFUSION ASSEMBLY. THE CLINICIANS CUT THE INFUSION LINE AT THE PUMP AND INSTALLED A STOPCOCK TO FACILITATE AIR REMOVAL FROM THE INFUSION LINE. THE PT WAS NOT IMPACTED BY THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PUMP NON-ROLLER TYPE BYPASS PUMP KFM CARDIAC ASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention