BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 7629877 · Received June 22, 2018

    Report

    Report Number
    9681839-2018-00038
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 22, 2018
    Manufacturer
    TERUMO CORPORATION
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    STN # BN 880217TERUMO BCT, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF FUJINOMIYA FACTORY OF TERUMOCORP., (MANUFACTURER). EXEMPTION NUMBER: E2015056.INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE WHOLE BLOOD COLLECTION SET WAS RETURNED BY THE CUSTOMER TO TERUMOBCT. THE PRODUCT WAS RECEIVED AND SENT TO THE LAB AT TERUMOBCT, PHOTOS WERE TAKEN OF THE RECEIVED PRODUCT AND THE PRODUCT WAS DISCARDED. THE MANUFACTURER USED THE PHOTOS THAT WERE PROVIDED BY THE CUSTOMER AND THE PHOTOS TAKEN BY TERUMO BCT, IN LIEU OF THE PRODUCT FOR THEIR INVESTIGATION. THE MANUFACTURING RECORDS, TEST RECORDS, AND INSPECTION RECORDS WERE REVIEWED FOR ABNORMALITIES AND NONE WERE FOUND. IN ADDITION, THE PRODUCT CONCERNED WAS WEIGHED FOR THE ENTIRE QUANTITY AFTER STERILIZATION AS WELL AS AFTER INDIVIDUAL PACKAGING TO CONTROL THE VOLUME OF BLOOD PRESERVATIVE SOLUTION. NO ABNORMALITIES WERE NOTED IN THE RESULTS OF WEIGHING. THE RECORDS REGARDING THE PARTICULATE REMOVAL RATES OF THE FILTER MEMBRANES OF THE REPORTED LOT NUMBER WERE REVIEWED AND ALL MEMBRANES CONFORMED TO ESTABLISHED SPECIFICATION. IN REGARD TO THE REPORTED LOT NUMBER, IT WAS INVESTIGATED WHETHER THERE HAD BEEN ANY SIMILAR COMPLAINTS REPORTED BY OTHER CUSTOMERS, AND CONFIRMED THAT THE SAME INCIDENT ASSOCIATED WITH THIS LOT NUMBER HAD NOT BEEN REPORTED BY ANY OTHER MEDICAL INSTITUTES AS OF JULY 19, 2018. SHIPPING TESTING WAS PERFORMED ON THE RETENTION SAMPLES FROM THE REPORTED LOT NUMBER. THE RETENTION SAMPLES WERE ALSO VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED WITH NO ABNORMALITIES NOTED. ALL PRODUCT CONFORMED TO THE ESTABLISHED SPECIFICATION. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED HEMOLYSIS REMAINS UNDETERMINED AT THIS TIME. THE REPORTED INCIDENT MAY HAVE OCCURRED BY A COMBINATION OF THE FOLLOWING COMMON FACTORS OF HEMOLYSIS IN BLOOD PRODUCTS: THERE IS A POSSIBILITY OF HEMOLYSIS IF THE BLOOD OF A DONOR HAS CHARACTERISTICS OF RED BLOOD CELL FRAGILITY. HEMOLYSIS IS LIKELY TO OCCUR IF BLOOD IS CONTAMINATED WITH BACTERIA CONTAINING HEMOLYSIN. BLOOD IS GRADUALLY CONGEALED AND EVENTUALLY HEMOLYZED WHEN IT IS COOLED BELOW -3°C. THERE ISA POSSIBILITY OF HEMOLYSIS DUE TO THIS FACTOR IF THE BLOOD BAG IS LOCALLY COOLED IN THE REFRIGERATOR. FILTRATION TIME IS EXTENDED BECAUSE THE FILTER IS LIKELY TO BE OCCLUDED, AND FURTHERMORE, WHEN RED BLOOD CELLS FLOW THROUGH SUCH AN OCCLUDED FILTER, PHYSICAL STRESS ON THE RED BLOOD CELLS MAY CAUSE HEMOLYSIS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD A UNIT OF PLASMA DERIVED FROM WHOLE BLOOD WITH A REDTINGE THEY BELIEVE IS DUE TO HEMOLYSIS. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF WHOLE BLOOD PROCESSING,THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473855 IMUFLEX BLOOD BAG SYSTEM IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTE CAK TERUMO CORPORATION 171024KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other