BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALLSMALL VOLUEME HME FILTER

    MDR report key: 1077344 · Received July 18, 2008

    Report

    Report Number
    9680602-2008-00006
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 14, 2008
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K834292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE INVOLVED DEVICE NOR ITS PACKING WAS RETURNED BY THE USER, SO NO DIRECT EVALUATION WAS POSSIBLE.THE USER HAD SECURED THE FILTER IN PLACE ON THE Y-CONNECTOR OF THE BREATHING CIRCUIT WHILE STILL IN THE UNIT PACKAGING. THE PACKAGING WAS THEN REMOVED LATER WITH THE FILTER STILL IN SITU. THIS PRACTICE MOST LIKELY LED TO A PIECE OF THE UNIT PACKAGING BEING PUNCHED OUT AND REMAINING IN AND OCCLUDING THE FILTER OUTLET PORT.IT APPEARS THAT THIS TEMPORARY STORAGE OF THE DEVICE BY ATTACHING IT TO THE BREATHING CIRCUIT WITHOUT REMOVING ITS UNIT PACKAGING WAS AN UNANTICIPATED AND UNFORESEEABLE MISAPPLICATION OF THE DEVICE.IN THE MULTIYEAR HISTORY OF THIS DEVICE IN THE UNIT PACKAGING FORM OF A POLYMER BAG, THERE HAS NEVER BEEN A SIMILAR REPORT.THIS REPORT THEN HAS BEEN CHARACTERIZED AS AN ISOLATED INSTANCE.AS A PREVENTATIVE ACTION, THE USER HAS BEEN INFORMED IN WRITING AS FOLLOWS:"PLEASE BE ADVISED THAT THE FILTER SHOULD ONLY BE REMOVED FROM THE UNIT PACKAGING USING THE DESIGNATED OPENING AREA AND THE FILTER SHOULD ONLY BE ATTACHED TO THE Y-CONNECTOR AFTER IT HAS BEEN REMOVED FROM THE UNIT PACKAGING."SUMMARY:THE DEVICE WAS MISUSED.ROOT CAUSE: USE ERROR, ISOLATED OCCURRENCE.UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IN THE ANESTHESIA DEPARTMENT OF A HEALTH CARE FACILITY, A PRACTICE HAD DEVELOPED WHEREBY, AT THE END OF THE DAY, THE DEVICE, STILL IN ITS POLYMER FILM POUCH, WOULD HAVE ITS 22 MM PORT LOOSELY INSERTED INTO THE CORRESPONDING 22 MM. PORT OF THE WYE CONNECTOR OF AN ANESTHESIA CIRCUIT. THE CIRCUIT, DEVICE, AND ANESTHESIA MACHINE WERE THUS STORED OVERNIGHT FOR USE THE NEXT DAY. IN THE CASE REPORTED, THE PORT OF DEVICE IN ITS POLYMER BAG PACKAGING APPEARED TO HAVE BEEN PUSHED SUFFICIENTLY INTO THE PORT OF THE WYE TO CUT OUT A DISC OF POLYMER FILM, WHICH ADHERED TO THE END OF THE PORT, COVERING THE LUMEN OF THE WYE-CONNECTOR PORT. AFTER THE DEVICE IN ITS POLY BAG WAS PULLED AWAY. THE USER DISCOVERED THIS SITUATION AND REPORTED THE FINDING AS A POTENTIAL HAZARD. THE ANESTHESIA DIRECTOR AT THE HEALTHCARE FACILITY HAS DIRECTED STAFF TO DISCONTINUE THE PRACTICE OF INSERTING THE DEVICE¿S PORT, WHILE STILL IN ITS BAG, INTO ANOTHER PORT. NO EFFECTS ON A PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALLSMALL VOLUEME HME FILTER PALL BREATHING SYSTEM FILTER CAH PALL NEWQUAY BB25G UNK

    Patients

    Seq Age Sex Outcome Treatment
    1