BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CENTRIMAG 24F RETURN CANNULA

    MDR report key: 4121632 · Received September 22, 2014

    Report

    Report Number
    2916596-2014-01680
    Event Type
    Death
    Date Received
    September 22, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 24, 2014
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. THE ATTACHED USER FACILITY REPORT # (B)(4) WAS RECEIVED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CANNULA WAS UNAVAILABLE FOR RETURN; AS A RESULT THE INVESTIGATION WAS PERFORMED ON SITE AT THE HOSPITAL. THE MANUFACTURER TRAVELED TO THE HOSPITAL TO CONDUCT A NON-DESTRUCTIVE ON-SITE EVALUATION OF THE PRODUCT IN QUESTION. THE CANNULA BOND WAS OBSERVED TO BE SEPARATED FROM THE CONNECTOR BODY. THE CANNULA WAS VISUALLY ASSESSED. THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A DEVICE-RELATED CAUSE FOR THE CANNULA BOND SEPARATION. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTRICULAR ASSIST DEVICE FOR ACUTE SUPPORT. THE PERFUSIONIST REPORTED THAT THE PT EXPIRED WHEN THE CANNULA SEPARATED AT THE CANNULA CONNECTOR AND THE INSIDE CONNECTOR OF THE CANNULA FROM THE TUBING PUMP DRAINED THE PT'S BLOOD INTO THE BED. THE HOSPITAL RISK MANAGEMENT TEAM IS INVOLVED AND CURRENTLY IN POSSESSION OF THE CONNECTOR PORTION OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587628 THORATEC CENTRIMAG 24F RETURN CANNULA KFM: CANNULA KFM THORATEC SWITZERLAND GMBH 201-50056 2014041042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death