BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1712582 · Received June 4, 2010

    Report

    Report Number
    2523676-2010-00040
    Event Type
    Injury
    Date Received
    June 4, 2010
    Date of Event
    April 19, 2010
    Report Date
    June 1, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR CATALOG # 7210953, LOT # 218028. A PRELIMINARY REPORT FROM THE ACTUAL MANUFACTURER INDICATES AT THIS POINT, IT IS UNK IF THE INCIDENT IS RELATED TO THE DEVICE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THERE ARE NO OTHER REPORTS AGAINST THE REPORTED CATALOG NUMBERS OR LOT NUMBERS.

    Description of Event or Problem · 1

    PT HAD SEVERE ALLERGIC REACTION DURING TREATMENT USING THE H.E.L.P. PRECIPITATE FILTER AND THE HAEMOSELECT M 0.3 FILTER ON A H.E.L.P. MACHINE. CUSTOMER IS REQUESTING ADDITIONAL INFORMATION ON THE MATERIALS. ADDITIONAL INFORMATION PROVIDED BY THE ATTENDING PHYSICIAN INDICATED THE PT PRESENTED HYPOTENSION AT 80/40 + TRONCULAR RASH ABOUT 45 MIN AFTER APHERESIS WAS STARTED ON APRIL 19 AM. THIS WAS THE FIRST OCCURRENCE OF SUCH SYMPTOMS IN THIS PARTICULAR PT AND IN OUR FH PATIENTS IN GENERAL. PHERESIS WAS IMMEDIATELY STOPPED AND SOLUMEDROL 40 MG IV + ZANTAC 150 MG IV + BENADRYL 50 MG PO + 1 LITER NORMAL SALINE WERE ADMINISTERED WITH SUCCESS. THE PT WAS THEN OBSERVED AT THE ICU FOR 6 HOURS BEFORE DISCHARGE. THE PT HAS BEEN EVALUATED BY AN IMMUNO-ALLERGIST WHO RULES OUT AN ALLERGY TO HEPARIN AND LATEX. WE CONCLUDED THAT THIS PT PRESENTED AN ANAPHYLACTIC REACTION BUT THE CAUSAL FACTOR REMAINS ELUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA H.E.L.P. PRECIPITATE FILTER, HAEMOSELECT M, 3M2 FPB B. BRAUN MEDICAL, INC. NA Z9944794

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization