BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUA SEAL CHEST DRAINAGE UNIT WITH ATS

    MDR report key: 125491 · Received October 10, 1997

    Report

    Report Number
    9611018-1997-00008
    Event Type
    Other
    Date Received
    October 10, 1997
    Date of Event
    September 4, 1997
    Report Date
    September 12, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOTS IN STOCK ARE 701959, 97E213T, 97E215T, 97E273T. SAMPLES FROM EACH LOT WERE RETURNED AND EVALUATED. ALL TUBING AND CONNECTOR SPECS WERE ACCEPTABLE. PULL OUT FORCE WAS FINE. NO PRODUCT PROBLEMS WERE IDENTIFIED. A "Y" CONNECTOR USED BY THE HOSP WAS RETURNED, MEASURED AND FOUND TO BE COMPATIBLE WITH THE CDU. THE USE OF TWO DIFFERENT TYPES OF CONNECTORS (ONLY ONE SUPPLIED BY SD&G) APPEARS TO HAVE CAUSED THE REPORTED PROBLEM. THE CUSTOMER WAS ADVISED TO ENSURE SNUG FIT WITH EACH CONNECTOR. USER ERROR APPEARS TO BE THE CAUSE OF THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    DURING THE WEEK OF 09/04 TO 09/10 THEY HAD THREE INCIDENTS IN WHICH THE PATIENT TUBE FROM THE AQUA SEAL DISCONNECTED FROM THE THORACIC CATHETER. TWO OCCURRED WHEN THE PATIENTS WERE TRANSPORTED FROM THE OR TO ICU. ONE OCCURRED AFTER THE PATIENT HAD BEEN IN ICU FOR FIVE DAYS. THIS PATIENT DEVELOPED A PNEUMOTHORAX AFTER THE TUBE DISCONNECTED. THE PNEUMOTHORAX HAS SINCE RESOLVED ITSELF. IN ALL CASES A NEW AQUA SEAL WAS PUT ON THE PATIENTS. THE CUSTOMER REPORTS, THEY NORMALLY PUT IN TWO CHEST TUBES AND CUT OFF THE CONNECTOR ON THE CDU AND REPLACE IT WITH THEIR "Y" CONNECTOR. THE CHEST TUBES ARE CONNECTED TO THE "Y" CONNECTOR. IN THIS INSTANCE, THE PATIENT TUBE CONNECTOR WAS USED AND THE STAFF DID NOT REALIZE THE CONNECTOR IS SMALLER THAN THE "Y" CONNECTOR. THE PATIENT TUBE CONNECTOR ON THE CDU DISCONNECTED FROM THE CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL CHEST DRAINAGE UNIT WITH ATS CHEST DRAINAGE/AUTO TRANSFUSION KDQ SHERWOOD MEDICAL INDUSTRIES NA 701959,97E213T,97E215T,97E273T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention