BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK COLLECTION CANISTER - 1200CC

    MDR report key: 8228942 · Received January 8, 2019

    Report

    Report Number
    1018233-2019-00165
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    March 22, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151798
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED PER REVIEW OF THE PRODUCT'S INSTRUCTIONS FOR USE; PAGE 7 OF THE IFU, ILLUSTRATES AND PROVIDES INSTRUCTIONS OF HOW TO SET UP THE DRYDOC WITH THE CANISTER. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿INSPECT THE SHIPPING BOX FOR DAMAGE. IF DAMAGE IS NOTICED, CONTACT LIBERATOR MEDICAL AT (B)(6) IMMEDIATELY. CAREFULLY REMOVE THE UNIT AND ALL CONTENTS, INCLUDING THE PACKING MATERIAL, FROM THE SHIPPING CONTAINER AND INSPECT CAREFULLY PRIOR TO USE. ¿ PLACE THE DRYDOC¿ VACUUM STATION (A) NEXT TO THE BED OR CHAIR WHERE IT WILL BE USED. IT MUST BE CLOSE ENOUGH FOR THE 70¿ PATIENT TUBING (B) TO EASILY REACH THE USER.* AVOID CREATING A TRIPPING HAZARD WITH THE PATIENT TUBING OR DRYDOC¿ VACUUM STATION. *THE DRYDOC¿ VACUUM STATION SHOULD BE PLACED ON A STABLE AND EVEN SURFACE AT OR BELOW THE USER¿S LEVEL. ¿ PLUG THE DRYDOC¿ VACUUM STATION POWER CORD INTO AN ELECTRICAL OUTLET. ¿ PLACE THE COLLECTION CANISTER (C) IN THE DRYDOC¿ VACUUM STATION BASE AND PRESS DOWN FIRMLY ON THE LID. ATTACH THE 16¿ VACUUM TUBING (D) TO THE DRYDOC¿ VACUUM STATION CONNECTOR PORT (E) AND THE CONNECTOR PORT LABELED ¿VACUUM¿ (F) ON THE COLLECTION CANISTER LID. ¿ ATTACH THE 70¿ PATIENT TUBING (B) TO THE CONNECTOR PORT LABELED ¿PATIENT¿ (G) ON THE COLLECTION CANISTER LID. CONNECT THE OTHER END OF THE 70¿ PATIENT TUBING SECURELY TO PUREWICK¿ FEC (H). CAUTION: IT IS IMPORTANT THAT THE PORT CONNECTIONS BE CONNECTED CORRECTLY FOR PROPER OPERATION OF THE DRYDOC¿ VACUUM STATION. ¿ TURN ON THE DRYDOC¿ VACUUM STATION BY PRESSING THE ON/OFF SWITCH ON TOP OF THE DRYDOC¿ VACUUM STATION. THE DRYDOC¿ VACUUM STATION IS FUNCTIONING WHEN THE SWITCH ILLUMINATES AND THE PUMP MAKES A SOFT HUMMING SOUND. THE SYSTEM IS NOW READY FOR USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT URINE WAS BEING DRAWN DIRECTLY INTO THE DRYDOC PUMP BECAUSE THE INSTRUCTIONS WERE NOT CLEAR ON HOW TO CONNECT THE COLLECTION CANISTER TO THE DRYDOC MACHINE. AS A RESULT, THERE WAS ALLEGED DAMAGE TO THE CANISTER LID FROM THE URINE. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT URINE WAS BEING DRAWN DIRECTLY INTO THE DRYDOC PUMP BECAUSE THE INSTRUCTIONS WERE NOT CLEAR ON HOW TO CONNECT THE COLLECTION CANISTER TO THE DRYDOC MACHINE. AS A RESULT, THERE WAS ALLEGED DAMAGE TO THE CANISTER LID FROM THE URINE. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18594 PUREWICK COLLECTION CANISTER - 1200CC COLLECTION CANISTER NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741151798

    Patients

    Seq Age Sex Outcome Treatment
    1