BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 4111136 · Received September 23, 2014

    Report

    Report Number
    1722028-2014-00389
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K831004
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE MACHINE WAS CHECKED OUT AT THE CUSTOMER SITE BY A TERUMO BCT SERVICE TECHNICIAN. FULL CHECKOUT AND FUNCTION TESTS WERE PERFORMED. MACHINE VOLTAGES, PRESSURES,PUMPS, PUMP OCCLUSIONS AND CENTRIFUGE, VALVES, CONTROL MONITORS, AND RED BLOOD CELL DETECTORS WERE ALL VERIFIED TO BE WITHIN MANUFACTURER SPECIFICATIONS. FULL FUNCTIONAL CHECKOUT REVEALED NO PROBLEMS AND THE MACHINE WAS RELEASED FOR USE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT,THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. ATTEMPTS TO OBTAIN THE DISCHARGE RECORD FOR THE CUSTOMER WERE NOT ANSWERED. ROOT CAUSE: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND ANALYSIS. THE MACHINE PASSED CHECKOUT WITH NO PROBLEMS FOUND. PER THE CUSTOMER, THE CAUSE OF THE PATIENT¿S DEATH WAS DUE TO THE PATIENT BEING CRITICALLY ILL (SEPTIC, HYPOTENSIVE, AND SUFFERED A CARDIAC EVENT).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT EXPIRED 3 HOURS AFTER BEING DISCONNECTED FROM A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE. AT MID PROCEDURE, THE PATIENT HAD UNSTABLE VITAL SIGNS AND THE MEDICAL DIRECTOR REQUESTED TO END THE PROCEDURE. THE CUSTOMER IS NOT ALLEGING ANY PROBLEM WITH THE MACHINE OR DISPOSABLE SET. PER THE CUSTOMER (THE RN), THE PATIENT'S DISEASE PROGRESSION WAS THE CAUSE OF DEATH. THE CUSTOMER DECLINED TO PROVIDE PATIENT'S IDENTIFIER AND WEIGHT. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH THERE IS NO ALLEGED DEVICE INVOLVEMENT OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592578 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA TPE SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR