BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL 1500CC CANISTER KIT, 2 ELBOWS

    MDR report key: 2070579 · Received April 13, 2011

    Report

    Report Number
    2320762-2011-00008
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    October 18, 2010
    Report Date
    October 21, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    DWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED FOR THE INVESTIGATION OF THE REPORTED MALFUNCTION. THE MANUFACTURER HAS DETERMINED THAT POSSIBLE ROOT CAUSES MAY BE: TUBING INADVERTENTLY DISCONNECTED FROM THE ELBOW OR A POOR CONNECTION. THE LID COULD HAVE AN OCCLUDED PORT DUE TO MOLD DAMAGE WHICH WOULD BE A MANUFACTURING DEFECT. THE LID COULD HAVE A SHORT SHOT (NON-FILL) OF A CAP, WHICH WOULD ALLOW VACUUM TO ESCAPE FROM THE COLLECTION UNIT. THIS WOULD BE A MANUFACTURING DEFECT. THE LID COULD HAVE BEEN HOOKED UP INCORRECTLY WITH PATIENT TUBING PLACED ON THE VACUUM PORT. BECAUSE OUR INVESTIGATION FINDINGS ARE INCONCLUSIVE WITH THE INFORMATION PROVIDED AND THE POSSIBLE DEFECTS NOTED ABOVE WERE NOT FOUND IN THE INVENTORY INSPECTION CONDUCTED, NO FURTHER ACTION CAN BE TAKEN AT THIS TIME. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    WHEN TRACHEAL SUCTIONING WAS ATTEMPTED IN A PATIENT'S ROOM, THE SUCTION WOULD NOT WORK. AGAIN ATTEMPTED SUCTION WITH A NEW LID AND CANISTER. TRIED ANOTHER SUCTION MACHINE, STILL DID NOT WORK. ANOTHER NURSE AND RESPIRATORY THERAPIST TRIED WITH THE SAME CANISTER AND LID AND STILL NO SUCTION. CODE BLUE WAS CALLED AND A SUCTION MACHINE AND CANISTER FROM THE CRASH CAST WAS USED WHICH DID SUCTION THE PATIENT. SUCTIONING WAS COMPLETED AND THE PATIENT WAS GIVEN EMOTIONAL SUPPORT AND REASSURANCE. HE WAS ASSURED THAT EXTRA SUCTION EQUIPMENT WOULD BE AVAILABLE IN HIS ROOM FOR BACK-UP. THE CANISTERS WERE DEFECTIVE AND WOULD NOT SUCTION. THE CANISTER WILL BE RETURNED TO DEROYAL INDUSTRIES, INC BY THE SPD DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL 1500CC CANISTER KIT, 2 ELBOWS CANISTER, SUCTION DWD DEROYAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R