BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL LEUKOCYTE REMOVAL FILTER FOR PLATELETS

    MDR report key: 3092451 · Received May 3, 2013

    Report

    Report Number
    9617787-2013-00003
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 2, 2013
    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 SINGLE SIGN ASSOCIATED WITH THIS EVENT OF TRANSFUSION REACTION (TXR) SUGGESTS THAT THE OCCURRENCE IS AN "ISOLATED HYPOTENSIVE REACTION". IN THIS CASE, THE REACTION MAY BE RELATED TO THE PRECEDING CARDIOPULMONARY BYPASS PROCEDURE. IT HAS BEEN RECOGNIZED THAT CARDIOPULMONARY BYPASS CAN RESULT IN AN INCREASED INCIDENCE OF VASOPLEGIA POST-OPERATIVELY. IN ADDITION, PRECEDING A CARDIAC PROCEDURE WITH AN ACE INHIBITOR HAS BEEN ASSOCIATED WITH THE DEVELOPMENT OF HYPOTENSION.2 OF THE POSSIBLE CAUSATIVE AGENTS IN TRANSFUSED PLATELETS, A SHORT-LIVED AGENT(S) IN THE PLATELETS MIGHT BE THOUGHT TO BE INVOLVED, SINCE THERE WAS A 10-15 MINUTE INTERVAL BEFORE THE RETURN TO BASELINE BLOOD PRESSURE. UPON REINSTITUTING THE TRANSFUSION, THE ABSENCE OF ANOTHER EPISODE OF HYPOTENSION IS PARADOXICAL. ADDITIONALLY, THE LACK OF HYPOTENSION FOLLOWING THE USE SUBSTITUTION OF A REPLACEMENT FILTER INDICATES THAT THE FILTER WAS NOT A FACTOR IN THE INITIAL EPISODE OF HYPOTENSION. ANOTHER CATEGORY OF VASO-ACTIVE AGENTS IN STORED PLATELETS IS CYTOKINES. 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 THERE IS NO DIRECT EVIDENCE THAT THE DEVICE WAS EITHER A CAUSAL OR CONTRIBUTORY FACTOR IN THE EVENT. ADDITIONALLY, REGARDING THE MANUFACTURING REGISTRATION NUMBER LISTED FOR THIS MDR INITIAL AND FINAL SUBMISSION, (B)(4), FOR THE INVOLVED DEVICE, PART NUMBER PL6KS, REPRESENTS WHERE THE PRODUCT WAS IN FACT MANUFACTURED IN 2010, PALL (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), AS OF 2013 HAS BEEN TRANSFERRED TO HAEMONETICS (B)(4) MANUFACTURING. REFERENCE: 1 ALFIREVIC ET AL, TRANSFUSION INCREASES THE RISK FOR VASOPLEGIA AFTER CARDIAC OPERATIONS, ANN THORAC SURG 2011; 92: 812-20 2 DEVBHANDARI MP, BALASUBRAMANIAN SK, CODISPOTI M, NZEWI OC, PRASAD SU., PREOPERATIVE ANGIOTENSIN-CONVERTING ENZYME INHIBITION CAN CAUSE SEVERE POST CPB VASODILATION--CURRENT UK OPINION, 2004 DEC; 12 (4) :346-9. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    A PATIENT WHO JUST PREVIOUSLY HAD SURGERY FOR TWO-VESSEL CORONARY ARTERY BYPASS: (LEFT MAIN AND CIRCUMFLEX ARTERIES OCCLUSIONS) WAS BEING TREATED IN THE CARDIOVASCULAR SURGERY INTENSIVE CARE UNIT. FIFTEEN MINUTES AFTER THE INITIATION OF A TRANSFUSION OF APHERESIS PLATELETS, THE PATIENT'S BLOOD PRESSURE FELL FROM 159/60 MMHG TO 90/40MMHG (MAP FROM 93 MMHG TO 56.6 MMHG BY ARTERIAL LINE). THE PLATELET TRANSFUSION WAS STOPPED AND 50 ML OF .9% NORMAL SALINE WAS INFUSED. A FRESH FILTER WAS INSTALLED AND THE PLATELET TRANSFUSION WAS RESTARTED. FIVE MINUTES LATER B/P INCREASED TO 150/90 MM HG AND SAO2 RETURNED TO 98%. THE PATIENT BECAME STABLE, WAS EXTUBATED 3 HOURS LATER AND WAS DISCHARGED 5 DAYS LATER. THIS DID NOT REPRESENT AN EXTENSION OF THE HOSPITALIZATION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193583 PALL LEUKOCYTE REMOVAL FILTER FOR PLATELETS MICROFILTER CAK PALL MEXICO MANUFACTURING PL6KS 1050188

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention