BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL EBDS

    MDR report key: 5695359 · Received June 2, 2016

    Report

    Report Number
    1219343-2016-00038
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 3, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    MZC
    PMA / PMN Number
    BK070063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATELET UNIT COLLECTED AT THE REPORTING FACILITY WAS SAMPLED AND STORED APPROPRIATELY ACCORDING TO THE FACILITY PROTOCOLS. THE UNIT PASSED BACTERIAL TESTING USING THE EBDS BACTERIAL DETECTION SYSTEM ON (B)(6) 2016 ON THE MOTHER PLATELET STORAGE BAG. THE PLATELET UNIT WAS TESTED AT THE HOSPITAL MICROBIOLOGY LAB AFTER THE TRANSFUSION REACTION AND WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE DEVICE IS NOT BEING RETURNED. THERE WAS NO PLATELET SAMPLE RETURNED TO HAEMONETICS FOR TESTING. STAPHYLOCOCCUS AUREUS SHOULD HAVE BEEN DETECTED BY THE EBDS IF THE TEST WAS PERFORMED CORRECTLY, BUT IN MITIGATION, IF THE SAMPLING WAS CONDUCTED AT A TIME WHEN THE BACTERIA IN THE MOTHER PLATELET STORAGE BAG HAD NOT GROWN SUFFICIENTLY TO BE CAPTURED IN THE EBDS POUCH DURING THE SAMPLING PROCESS, OR THE INCUBATION PERIOD/CONDITIONS WERE NOT CORRECT, THEN THE LEVEL FOR DETECTION BY THE EBDS WAS NOT REACHED. THERE ARE OTHER POSSIBLE POINTS IN THE SPLITTING INTO DAUGHTER PLATELET BAGS AND TRANSFUSION PREPARATION PROCESS THAT COULD HAVE BEEN THE CAUSE OF THE CONTAMINATION. THE ROOT CAUSE IS INCONCLUSIVE AS NO SAMPLES WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT THAT THE PALL ENHANCED BACTERIAL DETECTION SYSTEM (PALL EBDS)RETURNED A FALSE NEGATIVE RESULT WHICH RESULTED IN A TRANSFUSION REACTION. IT WAS REPORTED TO HAEMONETICS THAT A HOSPITAL END-USER TRANSFUSED ONE UNIT OF PLATELETS TO A PATIENT RECEIVING CHEMOTHERAPY FOR ACUTE MYELOID LEUKEMIA. THE COLLECTED PLATELET UNIT HAD BEEN TESTED AT THE COLLECTION SITE FOR BACTERIAL CONTAMINATION USING THE EBDS DEVICE. THE TEST DID NOT DETECT BACTERIAL GROWTH. NO TESTING WAS DONE AT THE HOSPITAL PRIOR TO TRANSFUSION. THE TRANSFUSION RESULTED IN A REACTION WITH FEVER WITH TEMPERATURE INCREASING FROM 37.5C TO 38.8C POST TRANSFUSION AS WELL AS CHILLS, HYPERTENSION, NAUSEA AND RASH. THERE WAS NO OTHER SIGNIFICANT ALTERATION IN THE PATIENT BASELINE VITAL SIGNS. THE TRANSFUSION WAS STOPPED AND A TRANSFUSION REACTION WORKUP INITIATED;UA AND BLOOD CULTURES SENT AS WELL AS BB SAMPLES. THE PATIENT HAS NO PRIOR HISTORY OF TRANSFUSION REACTIONS. THE PATIENT REQUIRED ADDITIONAL MEDICAL INTERVENTION. THE PATIENT WAS ALREADY RECEIVING VANCOMYCIN AND CEFEPIME ANTIBIOTICS PRIOR TO REACTION. FOLLOWING THE SEPTIC REACTION, ADDITIONAL ANTIBIOTICS, LINEZOLID, OXACILLIN, MEROPENEM, GENTAMYCIN, NAFCILLIN, LEVOFLOXACIN, AND CLINDAMYCIN WERE GIVEN. THE PATIENT CURRENTLY HAS NEGATIVE BLOOD CULTURES BUT HAS CAPILLARY LEAK AND RESPIRATORY FAILURE SECONDARY TO SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. HE IS NOW REQUIRING RESPIRATORY SUPPORT BY VENTILATION. THE PATIENT HAS ALSO BEEN GIVEN CHEMOTHERAPY FOR AML WHICH MAY BE CONTRIBUTING TO SOME OF HIS CURRENT SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350024 PALL EBDS SYSTEM,DETECTION,BACTERIAL, FOR PLATELET TRANSFUSION PRODUCTS MZC HAEMONETICS CORP BDS02

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization 400-03 BDS E SAMPLE BAG SET