BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 8529631 · Received April 18, 2019

    Report

    Report Number
    2531527-2019-00033
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 24, 2019
    Report Date
    July 10, 2019
    Manufacturer
    CARDIAC ASSIST INC.
    Product Code
    KFM
    PMA / PMN Number
    K110493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G4. DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: SUPPLEMENTAL MDR #2 INADVERTENTLY REPORTED THE DATE OF NEW INFORMATION AS 04/10/2019 INSTEAD OF 06/07/2019.

    Additional Manufacturer Narrative · 0

    MANUFACTURER, ADDRESS LINE 1; CORRECTED DATA: INITIAL MDR INADVERTENTLY REPORTED THE ADDRESS AS 640 ALPHA DRIVE INSTEAD OF 620 ALPHA DRIVE. ADDITIONAL DEVICE INFORMATION, SERIAL NUMBER; CORRECTED DATA: SUPPLEMENTAL MDR #1 INADVERTENTLY DID NOT REPORT THE DEVICE SERIAL NUMBER. ADDITIONAL DEVICE INFORMATION, EXPIRATION DATE; CORRECTED DATA: SUPPLEMENTAL MDR #1 INADVERTENTLY DID NOT REPORT THE DEVICE EXPIRATION DATE. IF FOLLOW-UP, WHAT TYPE; CORRECTED DATA: SUPPLEMENTAL MDR #1 INADVERTENTLY DID NOT SELECT ADDITIONAL INFORMATION. DEVICE MANUFACTURER DATE; CORRECTED DATA: SUPPLEMENTAL MDR #1 INADVERTENTLY DID NOT REPORT THE DEVICE MANUFACTURER DATE.

    Description of Event or Problem · 0

    SUPPLEMENTAL MDR #2 INADVERTENTLY REPORTED THE DATE OF NEW INFORMATION AS 04/10/2019 INSTEAD OF 06/07/2019.

    Description of Event or Problem · 0

    THE EXTERNAL VISUAL INSPECTION OF THE PUMP FOUND THERE WAS EVIDENCE OF BLOOD STAINING/CLOT ALONG THE PUMP OUTLET AND NO OTHER ANOMALIES. THE INTERNAL COMPONENT INSPECTION FOUND DRIED CLOT/DEPOSITS RUNNING FROM THE UPPER HOSING THROUGH THE PUMP OUTLET. ADDITIONALLY, A CLOT WAS PRESENT AT THE SHAFT SEAL INTERFACE. BASED ON THE BENCHTOP ANALYSIS OF THE PUMP, THE REPORTED COMPLAINT OF A CLOT WAS CONFIRMED. THE MOST LIKELY CAUSE OF THE CLOT FORMATION WAS THE LACK OF HEPARINIZATION DUE TO THE GI BLEED. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE PUMP WAS PERFORMED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY SWITCHED OUT THE TANDEMLIFE PUMP DUE TO A CLOT IN THE OUTFLOW LINE. THE TANDEMLIFE PUMP WAS SWITCHED TO A DIFFERENT PUMP AT THE BEDSIDE. THERE WERE NO ISSUES REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320620 TANDEMHEART PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM CARDIAC ASSIST INC. 5120-0000

    Patients

    Seq Age Sex Outcome Treatment
    1