BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS

    MDR report key: 3975018 · Received July 2, 2014

    Report

    Report Number
    3004365956-2014-00224
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION DOCUMENTED WAS PROVIDED BY (B)(6) - QUALITY COMPLIANCE AND SAFETY, SUPERVISOR FROM THE USER FACILITY. MS (B)(6) INDICATES THAT SHE DID NOT THINK THAT THE MELTED CIRCUIT HAD ANY EFFECT ON THE OUTCOME OF THE PT. SHE ALSO STATES THAT HER CONCERN WAS THAT A DEATH DID OCCUR AND A TELEFLEX PRODUCT WAS PART OF THE MEDICAL DEVICE CONFIGURATION AT THE TIME OF THE PT'S DEATH. THE CLAIM WAS CONFIRMED OF A MELT IN THE TUBING. AN INCOMPLETE CIRCUIT WAS RECEIVED. ONLY 1/2 OF ONE LIMB WAS RECEIVED. IT CANNOT BE DETERMINED IF IT IS THE INSPIRATORY OR EXPIRATORY LIMB. THE HEATED WIRES WERE CUT SO THE RESISTANCE CANNOT BE MEASURED. THE MELT WAS 6 INCHES FROM THE WATER TRAP. THE MELT WAS APPROXIMATELY 2 INCHES LONG. WITH ONLY A PART OF THE CIRCUIT RECEIVED, IT CANNOT BE DETERMINED WHAT CAUSED THE MELT. A SHARP EDGE TO THE MELTED SECTION DOES INDICATE THAT THE TUBING MAY HAVE BEEN PINCHED AT THE MELT LOCATION. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, AN INVESTIGATION WAS PERFORMED ON MATERIAL FROM PRODUCTION LINE. THE PRODUCT RELATED TO THIS COMPLAINT IS (B)(4) (CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS W/O). THIS PRODUCT IS CONFORMED WITH SUBASSEMBLIES THAT CONTAINS TWO RESISTANCE WIRES P/N 11735-01 AND 11735-02. SAMPLES FROM THE WAREHOUSE OF TELEFLEX, (B)(4) OF THESE SUBASSEMBLIES WERE VISUALLY INSPECTED AND NO KNOTS OR DAMAGE WERE FOUND THAT CAN LEAD TO THIS ISSUE. THE OVERALL LENGTH OF THESE SAMPLES WERE MEASURED ON THE (B)(4) FOUNDING THE OVERALL LENGTH (124-125") WITHIN SPECIFICATION. ALSO THE RESISTANCE WIRE WAS MEASURE ON THE (B)(4) AND THE RESISTANCE VALUES WERE FOUND WITHIN SPECIFICATION (12.80 - 14.30 OHMS).

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE STAFF FOUND A LARGE AMOUNT OF BLOOD IN THE EXPIRATORY TUBING/LIMB AS WELL AS A PARTIALLY MELTED CIRCUIT. THE INSPIRATORY LIMB WAS ALSO SATURATED WITH BLOOD. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386206 HUDSON CIRCUIT, HTD DUAL LIMB WITH WATER TRAPS BREATHING CIRCUIT CAG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death