BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-TYPE BLOOD SETS

    MDR report key: 4561965 · Received February 27, 2015

    Report

    Report Number
    9614279-2015-00008
    Event Type
    Injury
    Date Received
    February 27, 2015
    Report Date
    February 2, 2015
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K8402121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC INTERNAL REPORT # (B)(4). ONE (1) UNUSED, UNOPENED BLOOD SET, IDENTIFYING THE REPORTED LOT NUMBER 0061389717, WAS RECEIVED FOR EVALUATION. A THOROUGH REVIEW OF THE STERILIZATION RECORD WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THIS INCLUDED A REVIEW OF THE BIOLOGICAL INDICATOR (BI) AND BACTERIA ENDOTOXIN (LAL) TEST RESULTS. ALL RESULTS WERE FOUND TO BE ACCEPTABLE AND WITHIN SPECIFICATION. NO ABNORMALITIES WERE NOTED THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED EVENTS. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE PERFORMED FOR ALL LOT NUMBER CONTAINED WITHIN THE INVOLVED STERILIZATION LOAD REVEALED NO OTHER INCIDENTS OF THIS NATURE. THERE IS NO CURRENT INFO AVAILABLE TO SUGGEST THAT THE B BRAUN BLOOD SET CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IF ADDITIONAL PERTINENT INFO THAT IMPACTS THE DECISION AND RESULT OF THE INVESTIGATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT #3: REPORTS FIVE PATIENTS OVER THE LAST 2 MONTHS HAVE EXPERIENCED ALLERGIC TYPE REACTIONS SUCH AS RED FACE AND SHORTNESS OF BREATH. ONE PT EXPERIENCED HIVES. WITH ANOTHER PT, THE BABY'S HEART RATE DECREASED AND AN EMERGENCY C-SECTIONS WERE PERFORMED. THE REACTIONS OCCURRED APPROXIMATELY 2-3 MINUTES AFTER COMMENCEMENT OF IV THERAPY WITH PLASMALYTE (MANUFACTURED BY BAXTER). THIS HAS OCCURRED IN THE L AND D DEPARTMENT IN OTHERWISE HEALTHY WOMEN WITH NO KNOWN ALLERGIES. NO OTHER MEDICATION WAS ADMINISTERED TO THE PT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140266 Y-TYPE BLOOD SETS Y-TYPE BLOOD SETS FPA B. BRAUN OF DOMINICAN REPUBLIC NA 0061389717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PLASMALYTE IV THERAPY