BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG

    MDR report key: 3788446 · Received April 25, 2014

    Report

    Report Number
    2916596-2014-00698
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 3, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA WILL NOT BE RETURNING TO THE MANUFACTURER FOR EVALUATION, AS THE HOSPITAL STAFF REPORTEDLY DISPOSED OF IT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPORTED EVENT OF THE RED BAND SLIPPING OFF THE DRAINAGE KIT DURING SUPPORT IS UNABLE TO BE CONFIRMED AND COULD NOT BE CORRELATED TO THE REPORTED "NON-HEALING WOUND" AS THE CANNULA WAS DISPOSED OF AND IS NOT AVAILABLE FOR ANALYSIS. THE COLORED BAND ON THE CANNULA DO NOT PERFORM A FUNCTION DIRECTLY RELEVANT TO THE SUPPORT OF SYSTEM. THE BAND IDENTIFIES THE DRAINAGE (RED) AND RETURN (BLUE) CANNULA RESPECTIVELY. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE PRODUCT WILL NOT BE RETURNING. THE CANNULA WAS DISPOSED OF.

    Description of Event or Problem · 1

    THE PATIENT WAS SUPPORTED WITH AN EXTRACORPOREAL BLOOD PUMP SYSTEM FOR BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE PERFUSIONIST THAT THE PATIENT WAS WEANED OFF OF THE DEVICE ON (B)(6) 2014. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE FACILITY. THE PATIENT HAD A NON-HEALING WOUND IN THEIR ABDOMEN. DURING FURTHER EXAMINATION OF THE WOUND THEY FOUND A PIECE OF CIRCULAR RED TAPE WHICH APPEARED TO BE THE RED BAND OF THE CANNULA. IT WAS REPORTED THAT IT MAY HAVE SLIPPED OFF DURING THE TUNNELING OR REMOVAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250396 THORATEC CENTRIMAG CENTRIMAG DRAINAGE CANNULA DWF THORATEC SWITZERLAND GMBH 201-50067 2012091028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention