BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 5037889 · Received August 27, 2015

    Report

    Report Number
    2916596-2015-01563
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE FOR THE SEPARATION OF THE INLET TUBING FROM THE INLET PORT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED TO THE MANUFACTURER AND THERE IS A LACK OF OTHER INFORMATION CONCERNING THE USE OF THE PRODUCT PRIOR TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT AGE WAS ESTIMATED TO BE (B)(6). THE PATIENT WEIGHT WAS NOT PROVIDED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED, THEREFORE THE EXPIRATION DATE, MANUFACTURE DATE, AND UNIQUE DEVICE IDENTIFIER (UDI) ARE NOT AVAILABLE.ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE HOSPITAL CONTACT STATED THAT THE EVENT WAS UNDER INTERNAL REVIEW AND NO FURTHER INFORMATION COULD BE PROVIDED AND THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED BY AN EXTRACORPOREAL CIRCULATORY SUPPORT DEVICE THAT WAS INITIATED ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT WAS FOUND IN HIS ROOM HOLDING THE INFLOW TUBING OF THE DEVICE IN HIS HAND. THE INFLOW TUBING HAD BEEN COMPLETELY DISCONNECTED AT THE CONNECTION TO THE PUMP HEAD. THE PATIENT WAS COUGHING, EXPERIENCED SIGNIFICANT BLOOD LOSS AND AIR ENTRAINMENT INTO THE DEVICE CIRCUIT, AND SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN AMBULATING AT THE TIME OF THE INCIDENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569048 THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP KFM THORATEC SWITZERLAND GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death