BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 828228 · Received March 1, 2007

    Report

    Report Number
    2531527-2007-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 23, 2007
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INFUSATE SEEPAGE AT THE ADHESIVE INTERFACE BETWEEN THE UPPER AND LOWER HOUSINGS WAS CONFIRMED DURING FAILURE ANALYSIS. THE PUMP WAS DISASSEMBLED DURING THE ANALYSIS AND ALL COMPONENTS OF THE PUMP WERE FOUND TO BE FREE OF DAMAGE OR WEAR. PATIENT SUPPORT WAS NOT IMPACTED BY THE SEEPAGE AND THE PERFORMANCE OF THE PUMP WAS NOT DEGRADED. THE INCIDENT WAS NOTED APPROX 5 HOURS AFTER PT SUPPORT WAS INITIATED. PT SUPPORT WAS MAINTAINED FOR APPROX 5 DAYS WITH NO ADVERSE IMPACT TO THE PT. EVALUATION SUMMARY: THE SUBJECT PUMP WAS REC'D FROM THE HOSP ON 19 DAYS LATER AND PLACED INTO BIO-HAZARD CONTAINMENT. THE PUMP WAS DECONTAMINATED AND FAILURE ANALYSIS WAS CONDUCTED. VISUAL EXAMINATION OF THE PUMP FOUND NO SIGNS OF DAMAGE OR ABUSE. THE PUMP CONNECTOR AND INFUSION LINE HAD BEEN CUT OFF OF THE PUMP SO CONFIRMATION OF THE PUMP SERIAL NUMBER WAS NOT POSSIBLE. (NOTE-THE PUMP CONNECTOR IS PERMANENTLY MARKED WITH THE PUMP SERIAL NUMBER). THE PUMP LOWER HOUSING WAS PRIMED WITH SALINE AND LEAK TESTED UNDER PRESSURE. A SMALL AMOUNT OF SEEPAGE FROM THE PUMP AT THE INTERFACE BETWEEN THE UPPER AND LOWER HOUSINGS WAS CONFIRMED. THE AREA OF THE SEEPAGE WAS EXAMINED VISUALLY AND UNDER MAGNIFICATION, BUT NO SPECIFIC CAUSE FOR THE LEAK COULD BE DETERMINED. THE PUMP WAS DISASSEMBLED AND THE INTERNAL COMPONENTS WERE EXAMINED. NO EVIDENCE OF DAMAGE, EXCESSIVE WEAR, OR ABNORMAL OPERATION OF ANY COMPONENT WAS NOTED.

    Description of Event or Problem · 1

    IN 2007, INFUSATE LEAKAGE WAS NOTED FROM THE TANDEMHEART PUMP AT THE JOINT BETWEEN THE UPPER AND LOWER HOUSINGS. PATIENT SUPPORT WAS NOT INTERUPPTED AND CONTINUED NORMALLY UNTIL THE DEVICE WAS DISCONTINUED APPROX 5 DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *