BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL LEUKOCYTE REMOVAL FILTER FOR PLATELETS

    MDR report key: 2974907 · Received February 22, 2013

    Report

    Report Number
    9617787-2013-00001
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    November 5, 2012
    Report Date
    May 2, 2013
    Manufacturer
    PALL MEXICO MANUFACTURING
    Product Code
    CAK
    PMA / PMN Number
    K873667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECTRUM OF SIGNS AND SYMPTOMS ASSOCIATED WITH THIS EVENT SUGGESTS SEVERAL POSSIBLE TYPES OF TRANSFUSION REACTIONS (TXR). THE LENGTH OF THE TIME PERIOD (4 HOURS) REQUIRED TO STABILIZE THE BLOOD PRESSURE EXCLUDES A SHORT HALF-LIFE ENTITY IN THE TRANSFUSED BLOOD AS A CAUSAL FACTOR. TWO OTHER TYPES OF TXR ARE KNOWN TO PRESENT THESE SIGNS AND SYMPTOMS: - A SEPTIC REACTION TO BACTERIALLY CONTAMINATED BLOOD; - AN ANAPHYLACTIC REACTION TO A CONSTITUENT OF THE PLATELET COMPONENT BEING TRANSFUSED. A SEPTIC REACTION: SINCE THERE WAS NO MENTION OF CULTURES BEING TAKEN FROM THE PATIENT AND THE RESIDUAL IN THE PLATELET BAG, IT IS POSSIBLE THAT BACTERIAL CONTAMINATION HAD BEEN RULED OUT. THE TRANSFUSION RECIPIENT DID NOT BECOME FEBRILE. IN ADDITION, THE MEDICATIONS USED TO TREAT THE TXR DID NOT INCLUDE ANTIBIOTICS. AN ANAPHYLACTIC REACTION IS LEFT AS THE MOST LIKELY SOURCE OF THE HYPOTENSION AND OTHER SYMPTOMS. ANAPHYLACTIC REACTIONS OCCUR INDEPENDENTLY OF THE PRESENCE OF LEUKOCYTE REDUCTION FILTERS, ARE CAUSED BY THE TRANSFUSION RECIPIENTS REACTION TO A COMPONENT OF THE PLASMA IN WHICH THE PLATELETS ARE SUSPENDED. THE LOT HISTORY RECORD WAS REVIEWED FOR PRODUCT PL6KS LOT# 1050188 SHOWED THAT LOT MET ALL CRITERIA FOR RELEASE. THERE WERE NO RELEVANT DEVIATIONS OF NON-CONFORMANCES RECORDED FOR THE MANUFACTURING PROCESSES. THIS EVENT IS ONE OF THREE REPORTED BY THE SAME USER FACILITY OVER A PERIOD OF FOUR MONTHS. NO OTHER SUCH REPORTS HAVE BEEN RECEIVED IN THE PAST FIVE YEARS. SUMMARY THE DEVICE WAS NEITHER A CAUSAL NOR CONTRIBUTORY FACTOR IN THE EVENT. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    REPORTS OF THIS NATURE HAVE BEEN ADDRESSED BY THE FDA, PLEASE REFERENCE THE BELOW WEBSITE LINK FOR DETAILS: HTTP://WWW.FDA.GOV/MEDICALDEVICES/SAFETY/ALERTSANDNOTICES/PUBLICHEALTHNOTIFICATIONS/UCM062284.HTM ADDITIONALLY, REGARDING THE MANUFACTURING REGISTRATION NUMBER LISTED FOR THIS MDR INITIAL SUBMISSION, (B)(4), FOR THE INVOLVED DEVICE, PART NUMBER PL6KS, REPRESENTS WHERE THE PRODUCT WAS IN FACT MANUFACTURED IN 2010, (B)(4) MANUFACTURING FACILITY. SINCE THEN IT IS IMPORTANT TO NOTE THAT HAEMONETIC'S CORPORATION HAS RECENTLY ACQUIRED CERTAIN ASSETS OF THE PALL CORPORATION BLOOD COLLECTION, FILTRATION AND PROCESS PRODUCT LINES. AS SUCH, THE ACTIVE REGISTRATION NUMBER ,(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETAINED BY THE CUSTOMER, SO DIRECT EVALUATION WAS NOT POSSIBLE. THE USER DID NOT REPORT THE LOT NUMBER OF THE INVOLVED DEVICE, SO REVIEW OF THE MANUFACTURING HISTORY OF THE MANUFACTURING LOT WAS NOT POSSIBLE. ADDITIONAL INFORMATION TO THAT INITIALLY REPORTED WAS REQUESTED SEVERAL TIMES, BUT WAS NOT RESPONDED TO. FOR THE REASONS ABOVE NO FURTHER EVALUATION COULD BE CONDUCTED. AS WAS MENTIONED IN THE FIRM'S INITIAL MEDWATCH REPORT, THIS TYPE OF TRANSFUSION REACTION WHEN LEUKOCYTE REDUCTION FILTERS WERE IN USE HAS BEEN DESCRIBED IN A 1999 FDA PUBLIC HEALTH NOTIFICATION (ATTACHED). NO SIMILAR REPORTS RELATING TO PLATELET TRANSFUSION FILTERS HAVE BEEN RECEIVED IN THE PAST TEN YEARS. THERE IS NO INDICATION THAT THE REPORTED EVENT WAS RELATED TO THE MANUFACTURING PROCESS. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CARDIOVASCULAR SURGERY AREA WHEN TRANSFUSING PLATELETS WITH THE DEVICE, A PATIENT BECAME HYPOTENSIVE.

    Description of Event or Problem · 1

    AFTER TRANSFER TO THE CARDIOVASCULAR SURGERY INTENSIVE CARE UNIT FOLLOWING A FEMORO-POPLITEAL BYPASS (FEM-POP) SURGICAL PROCEDURE, THE PATIENT RECEIVED AN APHERESIS PLATELET TRANSFUSION VIA A CENTRAL VENOUS CATHETER. TWENTY-TWO MINUTES AFTER THE START OF THE TRANSFUSION, THE PATIENT DEVELOPED SEVERE HYPOTENSION (B/P FELL FROM 101/50MMHG TO 46/36), AN INCREASE IN HEART RATE (126/MIN), CHEST PAIN, RASH, NAUSEA AND VOMITING. BLOOD COMPONENT NUMBER: (B)(6). BLOOD PRODUCT SOURCE: (B)(6) BLOOD BANK. MEDICATIONS ADMINISTERED DURING TREATMENT OF TXR-DESCONTINUED PLATELETS APHERESIS STAT, BENADRYL 50 MGS IV, SOLUCORTEF 100 MG IV, ZOFRAN 4 MGS IV, EPINEPHRINE 1 MG IN 250 ML. 9% NORMAL SALINE AT 50 ML/HOUR, DOPAMINE 400 MG/ 250 ML D/W 5% AT 8 MCG/ HOUR (24 ML/HR) OTHER POST-TXR TREATMENT: 150 MEQ OF SODIUM BICARBONATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77907 PALL LEUKOCYTE REMOVAL FILTER FOR PLATELETS MICROFILTER, BLOOD CAK PALL MEXICO MANUFACTURING PL6KS 1050188

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R