BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL LEUKOGUARD

    MDR report key: 1081909 · Received July 29, 2008

    Report

    Report Number
    9680602-2008-00008
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    PALL NEWQUAY
    Product Code
    DTM
    PMA / PMN Number
    K902518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO USED DEVICES WERE RETURNED FROM THE REPORTING USER FACILITY.AN EXTERNAL EXAMINATION SHOWED NO EXTERNAL DAMAGE AND THE RETURNED PRODUCTS APPEARED REPRESENTATIVE OF CURRENT MANUFACTURED PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER OF THE INVOLVED DEVICES DISCLOSED NO DEVIATION IN RELEASE TESTING REQUIREMENTS THAT WOULD RELATE TO THE REPORTER'S EXPERIENCE. A FLOW RATE ANALYSIS WAS PERFORMED ON THE RETURNED FILTERS, IDENTIFIED UPON RECEIPT AS DEVICE "A" AND DEVICE "B" . IT WAS NOT CLEAR WHICH OF FILTER A OR B CORRESPONDED WITH 9680602-2008-00007 AND WITH 9680602-2008-00008.THE DEVICES WERE SUBJECT TO A FLOW VS. DELTA P TESTING AT FLOWS RANGING FROM 1-5 L/MIN AT ONE L/MIN INCREMENTS. THE RESULTS ARE DEPICTED IN THE FOLLOWING TABLE.FLOW RATE (L/MIN) DELTA P (MM HG) FILTER A FILTER B CONTROL1 003 002 0012 005 003 0023 008 008 0044 012 009 0075 017 013 011BOTH RETURNED DEVICES DISPLAYED A SOMEWHAT HIGHER FLOW RESISTANCE THAN THE UNUSED DEVICE SERVING AS A CONTROL. THIS WOULD BE EXPECTED FROM A USED FILTER COMPARED TO AN UNUSED FILTER. THE MAGNITUDE OF THE INCREMENTS, EVEN WHEN THE TAKING INTO ACCOUNT THAT THE TEST FLUID WAS WATER, NOT HEMODILUTED BLOOD, CANNOT BE CONSIDERED AS WHAT WOULD BE EXPECTED IN A "BLOCKED" DEVICE.DURING THE FLOW/DELTA P TESTING, AIR VENTING ANOMALIES WERE OBSERVED IN BOTH RETURNED DEVICES: BOTH AIR VENTS LEAKED AND BUBBLED DURING AIR VENTING. THESE ANOMALIES WOULD APPEAR TO BE THE SOURCE OF THE SMALL VOLUME OF LEAKAGE OBSERVED AT VARIOUS LOCATIONS IN THE DEVICE, RESULTING FROM THE PROGRESSION DUE TO GRAVITY OF LIQUID ALONG THE DEVICE HOUSING AND ITS ASSOCIATED TUBING.IT IS UNCLEAR WHETHER THESE ANOMALIES MIGHT BE RELATED TO THE ELEVATED ARTERIAL LINE PRESSURES REPORTED IMMEDIATELY UPON INITIATING CARDIOPULMONARY BYPASS.OVER THE COURSE OF THE LAST TWO DECADES, IT HAS BEEN PROPOSED THAT INSTANCES OF AN IMMEDIATE ARTERIAL LINE PRESSURE ELEVATION MIGHT BE RELATED TO AN IMPINGEMENT OF AGGREGATED PLATELETS IN THE PERFUSATE BLOCKING THE FLOW PATHWAYS OF THE DEVICE, AND THAT THE TRANSIENT AND REVERSIBLE NATURE OF SUCH PLATELET AGGREGATION WOULD THEN RESULT IN A DEVICE WITH LITTLE OR NO APPARENT BLOCKAGE. THE EVENT, AS DESCRIBED BY THE USER, AND THE RESULTS OF THE FIRM'S INVESTIGATION, WOULD BE CONSISTENT WITH SUCH A MECHANISM.IN SUCH EVENTS, THERE HAS NOT PREVIOUSLY BEEN A COINCIDENCE OF AIR VENTING ANOMALIES AND LEAKAGE AS WAS DESCRIBED IN THESE EVENTS.FINALLY, IT IS NOT CLEAR WHETHER THE REPORTED HEMATURIA REPORTED TO HAVE APPEARED 30 MINUTES FOLLOWING THESE EVENTS IS ETIOLOGICALLY RELATED, ESPECIALLY IN THE ABSENCE OF PATIENT AND PERFUSION HISTORIES THAT WOULD BETTER DEFINE THE ORIGIN OF THIS OCCURRENCE. THERE EXIST DURING CARDIOPULMONARY BYPASS AND THE ASSOCIATED SURGICAL PROCEDURES A NUMBER OF POTENTIAL ETIOLOGIES OF HEMATURIA.FINALLY, IT SHOULD BE NOTED THAT THE PRODUCT LABELING COMMUNICATES THE POTENTIAL FOR ELEVATED ARTERIAL LINE PRESSURES:"THERE ARE INCIDENTS OF HIGH LINE PRESSURE ASSOCIATED WITH THE USE OF THIS FILTER THAT MAY REQUIRE THE USE OF THE FILTER BYPASS LINE."SUMMARY: THE USER'S REPORT WAS CONFIRMED AS FOLLOWS: LEAKAGE WAS LOCALIZED TO THE AIR VENT MEMBRANE AND PRESSURE DIFFERENTIAL PRESSURE WAS ONLY SLIGHTLY ELEVATED. THE POSSIBLE RELATIONSHIP, IF ANY, BETWEEN THE SLIGHT PRESSURE INCREASE AND THE SIGNS AND SYMPTOMS EXHIBITED BY THE PATIENT IS INDETERMINATE DUE TO INABILITY TO OBTAIN PATIENT, LABORATORY AND OPERATING ROOM DATA FROM THE USER FACILITY.UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A CARDIAC SURGERY, AN ANOMALY WAS EXPERIENCED RELATED TO THE PERFORMANCE OF THE DEVICE, WHICH WAS LOCATED IN THE ARTERIAL LINE OF THE CARDIOPULMONARY BYPASS CIRCUIT. IMMEDIATELY AFTER THE PRE-BYPASS CIRCULATION, PULSATILE MOVEMENT WAS OBSERVED IN THE SEGMENT OF TUBING LEADING FROM THE ARTERIAL OUTLET OF THE OXYGENATOR TO THE INLET OF THE DEVICE. ARTERIAL LINE PRESSURE INCREASED AND THEY COULD NOT BE NORMALIZED, PERFUSATE FLOW WAS THEN DIVERTED THROUGH THE DEVICE BYPASS TUBING, AND THE PULSATILE MOVEMENT AND ELEVATED LINE PRESSURE RESOLVED. THE PATIENT EXPIRED AT A LATER TIME, BUT THE REPORTER INDICATED THAT THE CAUSE OF DEATH WAS NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL LEUKOGUARD LD-SIX ARTERIAL BLOOD FILTER FOR EXTRACORPOREAL SERVICE DTM PALL NEWQUAY LG6B 07-323

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention