BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA TPE SET

    MDR report key: 2498342 · Received March 13, 2012

    Report

    Report Number
    1722028-2012-00148
    Event Type
    Other
    Date Received
    March 13, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 15, 2012
    Manufacturer
    CARIDIANBCT
    Product Code
    FRO
    PMA / PMN Number
    K020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: PER THE CUSTOMER, THE PATIENT HAD RUN OUT OF HER MEDICATIONS THE FRIDAY BEFORE THE PROCEDURE, AND HAD NOT HAD THEM REFILLED. SHE WAS NOT ON ANY ACE INHIBITORS. THE PHYSICIANS AND THE PHARMACIST AT THE CUSTOMER SITE BELIEVE THE REACTION WAS RELATED TO THE ALBUMIN THE PATIENT RECEIVED. THE PATIENT'S PHYSICIAN HAS DECIDED TO CHANGE THE COURSE OF TREATMENT AND NOT PERFORM APHERESIS SINCE THE SECOND REACTION WAS MUCH MORE SEVERE THAN THE FIRST DAY. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD WAS REVIEWED. NOTHING WAS FOUND THAT WAS RELATED TO THIS EVENT. ROOT CAUSE: THE PATIENT'S PHYSICIAN AND PHARMACIST DETERMINED THAT THE REACTION WAS RELATED TO THE ALBUMIN THE PATIENT RECEIVED. NO ISSUES WITH THE COBE SPECTRA SYSTEM WERE REPORTED BY THE CUSTOMER. ALLERGIC REACTIONS ARE A KNOWN POSSIBLE SIDE EFFECT OF APHERESIS PROCEDURES. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, TRANSFUSION REACTIONS MAY OCCUR IN AS MANY AS (B)(4) OF PROCEDURES. THE COBE SPECTRA OPERATOR'S MANUAL WARNS OPERATORS THAT WHEN USING BIOLOGICALLY DERIVED REPLACEMENT FLUIDS, THE PATIENT SHOULD BE CLOSELY MONITORED FOR REACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 15 MINUTES INTO A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE USING 5% ALBUMIN AS THE REPLACEMENT SOLUTION, THE PATIENT BEGAN HAVING HIVES WITH DIFFICULTY BREATHING AND WHEEZING. PHYSICIANS AND THE CODE CART WERE CALLED. THE PROCEDURE WAS STOPPED; ADDITIONAL IV MEDICATIONS WERE GIVEN PER THE PHYSICIANS TO TREAT THE REACTION. THE REACTION CLEARED AND PATIENT WAS OK AFTER THAT. THE PATIENT WAS PRE-MEDICATED "HEAVILY" WITH TYLENOL, BENADRYL, AND STEROIDS. THIS WAS THE PATIENT'S SECOND TPE PROCEDURE. THE FIRST PROCEDURE RESULTED IN HIVES REQUIRING MEDICATION, WHICH WAS REPORTED ON MEDWATCH REPORT # 1722028-2012-00147. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER, DATE OF BIRTH OR WEIGHT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA TPE SET SEPARATOR, AUTOMATED, BLOOD CELL, DIAG FRO CARIDIANBCT P1U15202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BEHRING IN 250ML BOTTLES, FENTANYL AND VERSED FOR| THE LINE PLACEMENT.| ALBUMIN WAS PRE-BOTTLED FROM THE MANUFACTURER CSL