BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 4291392 · Received December 2, 2014

    Report

    Report Number
    1722028-2014-00475
    Event Type
    Death
    Date Received
    December 2, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 7, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH ANE VENT 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: PER THE CUSTOMER, THE ICU NURSE WAS CONCERNED ABOUT RHYTHM AND EKG CHANGES PRIOR TO THE CONNECTION TO THE APHERESIS MACHINE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THE DEATH OF THE PATIENT. THE APHERESIS NURSE INDICATED THAT THE PATIENT EXPIRED APPROX 1-2 MINUTES AFTER BEING CONNECTED TO THE MACHINE FOR TREATMENT. THE PROCEDURE WAS IN THE PRIME/DIVERT PHASE. ADDITIONAL PATIENT CONDITION DETAILS WERE REQUESTED, BUT NOT PROVIDED BY THE CUSTOMER. ROOT CAUSE: THE DISPOSABLE SET WAS UNAVAILABLE FOR INVESTIGATION. BASED ON THE PATIENT'S SIGNIFICANT MEDICAL HISTORY, AND THE ICU NURSES CONCERN OVER THE PATIENT'S UNEXPECTED RHYTHM AND EKG CHANGES PRIOR TO STARTING THE PROCEDURE. THE ROOT CAUSE OF THE PATIENT'S DEATH, WAS DUE TO THE PATIENT'S MEDICAL CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT JUST AFTER STARTING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE ON A VENTILATED ICU PATIENT, THE PATIENT'S HEART RATE DECREASED AND RESPIRATORY RATE INCREASED. THE ICU NURSE CALLED A CODE AND THE APHERESIS NURSE DISCONNECTED THE PATIENT FROM THE TPE. CPR AND MEDICATION WERE GIVEN IN ATTEMPTS TO RESUSCITATE THE PATIENT, BUT THE PATIENT EXPIRED AFTER MULTIPLE ATTEMPTS. PER THE CUSTOMER, PATIENT'S CONDITION WAS THE CAUSE OF THE CARDIAC ARREST AND THE PATIENT'S INCIDENT IS NOT ALLEGED TO BE RELATED TO THE APHERESIS MACHINE OR THE DISPOSABLE APHERESIS SET USED DURING THE PROCEDURE. PATIENT'S IDENTIFIER IS NOT AVAILABLE AT THIS TIME. 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 AT THIS TIME IT IS NOT ALLEGED OR SUSPECTED THAT THE DEVICE WAS A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776190 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA TPE SET GKT TERUMO BCT 07W15275

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR