BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL POSIDYNE NEO FILTER

    MDR report key: 1359027 · Received April 13, 2009

    Report

    Report Number
    9680602-2009-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    March 7, 2009
    Report Date
    April 13, 2009
    Manufacturer
    PALL LIFE SCIENCES PUERTO RICO, LLC
    Product Code
    FPB
    PMA / PMN Number
    K850825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL EVALUATION OF THE RETURNED NEO96E FILTER WAS PERFORMED BY OUR SCIENTIFIC AND LABORATORY SERVICES (SLS). SLS PRIMED THE FILTER WITH 0.9% SALINE AND OBSERVED THE PRESENCE OF AIR IN THE DOWNSTREAM TUBING. THEREFORE THE CUSTOMER'S REPORT WAS CONFIRMED. THE NEO96E FILTER WAS SUBSEQUENTLY FORWARDED TO OUR MANUFACTURING FACILITY FOR FURTHER INVESTIGATION. WHEN THE FILTER WAS CUT OPEN IT WAS OBSERVED THAT PART OF THE FILTER MEDIA HAD DETACHED FROM THE FILTER HOUSING ALLOWING AIR TO PASS DOWNSTREAM OF THE FILTER MEDIA. THE ROOT CAUSE OF THE DETACHED AREA OF FILTER MEDIA IS INDETERMINATE. HOWEVER TWO POSSIBILITIES EXIST: THIS DEVIATION MAY HAVE BEEN INADVERTENTLY CAUSED DURING THE MANUFACTURING PROCESS. HOWEVER, THE MEDIA APPEARED TO HAVE BEEN CLEANLY CUT AND DID NOT EXHIBIT ANY EVIDENCE OF HAVING BEEN DAMAGED DURING THE MANUFACTURING PROCESS. NEVERTHELESS A MANUFACTURING ROOT CAUSE FOR THIS DEVIATION CANNOT BE RULED OUT. UNFORTUNATELY A REVIEW OF THE IMPLICATED FILTER'S MANUFACTURING RECORDS WAS NOT POSSIBLE AS THE CUSTOMER DID NOT PROVIDE US WITH A LOT NUMBER. ALTERNATIVELY THE FILTER MAY HAVE BEEN INADVERTENTLY DAMAGED BY THE USER DURING PRIMING. AS STATED IN THE NEO96E INSTRUCTIONS FOR USE THE MAXIMUM RECOMMENDED WORKING PRESSURE IS 1500 MMHG (2 BAR, APPROX 30 PSI). IF A PRESSURE IN EXCESS OF THIS FIGURE WAS EXERTED ON THE FILTER DURING PRIMING (FOR EXAMPLE BY USING A SMALL VOLUME SYRINGE) THIS COULD HAVE CAUSED THE MEDIA TO BECOME PARTIALLY DETACHED FROM THE FILTER HOUSING. NO INFORMATION WAS PROVIDED FROM THE USER REGARDING HOW THE FILTER WAS PRIMED OR THE PRESSURE THAT WAS APPLIED DURING PRIMING. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRAVENOUS FLUID ADMINISTRATION, BUBBLES WERE OBSERVED IN THE LINE AFTER THE DEVICE. THE USER THOUGHT THE DEVICE MIGHT NOT HAVE BEEN PRIMED PROPERLY, AND REPRIMED THE DEVICE BUT BUBBLES WERE AGAIN OBSERVED, THIS TIME AT THE OUTLET OF THE DEVICE. NO PATIENT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL POSIDYNE NEO FILTER EXTENDED LIFE DISPOSABLE FOR IV THERAPY FPB PALL LIFE SCIENCES PUERTO RICO, LLC NEO96E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1