BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASEPT PLEURAL DRAINAGE SYSTEM

    MDR report key: 1917981 · Received December 6, 2010

    Report

    Report Number
    2032582-2010-00007
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 3, 2010
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    DWM
    PMA / PMN Number
    K093307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ASEPT VALVE FROM M7001. BATCH RECORD REVIEW: LOT NUMBER PROVIDED BY COMPLAINANT DOES NOT CORRESPOND WITH RETURNED DEVICE. LOT 1004-020 IS FOR A M7002, DHR WAS COMPLETE AND IN ORDER. VISUAL INSPECTION: IDENTIFIED AND REMOVED ORGANIC FOREIGN MASS WITHIN THE VALVE ADAPTER. THE FOREIGN MASS WAS 0.5" LENGTH X 0.03" DIAMETER (SEE SCANNED PAGE). ONCE CLEARED, FLUID COULD BE INJECTED AND ASPIRATED THROUGH THE VALVE. FUNCTIONAL INSPECTION: FLOW TEST RESULTS: 123 ML/MIN (SPECIFICATION 60 ML/MIN). PRESSURE TEST RESULTS: NO PRESSURE LEAK AT 20 PSI/30 SECONDS (SPECIFICATION NO LEAK AT 20 PSI/30 SECONDS) VACUUM TEST RESULTS: NO VACUUM LEAK AT 27 INHG/120 SECONDS (SPECIFICATION NO LEAK AT 27 INHG/120 SECONDS). CONCLUSION: THE FOREIGN MASS OCCLUDED THE VALVE PREVENTING THE VALVE FROM PERFORMING AS INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED "INITIAL PLACEMENT WENT WELL ON (B)(6) 2010. DRAINAGE PERFORMED PROPERLY FOR A 16 DAY PERIOD. OVER TIME, THE VALVE BECAME CLOGGED AND WAS NOT PERFORMING AS INDICATED." PT OUTCOME: "THE VALVE CLOGGING PROBLEM ALLOWED FOR FLUID TO BACK UP IN THE PLEURAL SPACE AND LEAD TO INCREASED PRESSURE. A CT SCAN WAS PERFORMED ALONG WITH A THORACENTESIS ON (B)(6) 2010. THE VALVE WAS REPLACED WITH A VALVE FROM A PLEURX KIT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASEPT PLEURAL DRAINAGE SYSTEM APPARATUS, SUCTION, PATIENT CARE DWM PFM MEDICAL, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1