BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS

    MDR report key: 6141062 · Received December 2, 2016

    Report

    Report Number
    3012307300-2016-00479
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    April 10, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. THE HOSPITAL HAS NOTICED THIS SCENARIO OCCURRING FOR ABOUT A MONTH WITH EVERY ANESTHESIA CIRCUIT USED PRIOR TO THE DATE OF THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, BECAME AWARE THAT A CORRECTION WAS NEEDED ON THE AWARE DATE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT 21 DEVICES CONTRIBUTED TO 21 REPORTED EVENTS (ONE DEVICE PER EVENT). THE CUSTOMER RETURNED ONE DEVICE FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH OCCURRENCE THE DEVICE WAS ASSOCIATED WITH; THEREFORE, THE EVALUATION OF THE DEVICE WILL BE USED FOR THE MEDWATCH. THE FOLLOWING MFRS WERE SUBMITTED RELATED TO THE EVALUATION: 3012307300-2016-00299, 3012307300-2016-00354, 3012307300-2016-00461, 3012307300-2016-00462, 3012307300-2016-00463, 3012307300-2016-00464, 3012307300-2016-00465, 3012307300-2016-00466, 3012307300-2016-00467, 3012307300-2016-00468, 3012307300-2016-00469, 3012307300-2016-00470, 3012307300-2016-00471, 3012307300-2016-00472, 3012307300-2016-00473, 3012307300-2016-00474, 3012307300-2016-00475, 3012307300-2016-00476, 3012307300-2016-00477, 3012307300-2016-00478, AND 3012307300-2016-00479. ONE PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUIT (LOT NUMBER 3205026) WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RECEIVED WITHIN ITS ORIGINAL OPENED PACKAGE. THE SAMPLE'S ELBOW AND WYE WERE MEASURED USING A COORDINATE MEASURING MACHINE. EACH COMPONENT'S INNER DIAMETER AND OUTER DIAMETER MEASURED WITHIN SPECIFICATIONS. NEXT, A FORCE TEST WAS PERFORMED BY CONNECTING THE 90 DEGREE ELBOW TO A TEST FIXTURE WHICH PULLS THE CIRCUIT UNTIL A SEPARATION OCCURS. THIS TEST FOUND THE WYE AND 90 DEGREE ELBOW TO SEPARATE WITHIN THE SPECIFIED LIMITS. INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED ISSUE AND FOUND THAT THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGICAL PROCEDURE ANESTHESIA ADMINISTRATION, THE CONNECTOR HAS BEEN DISCONNECTING ON THE ANESTHESIA CIRCUITS. IT WAS REPORTED THAT THE DISCONNECTION IS OCCURRING BETWEEN THE "WYE PIECE" AND THE "90 DEGREE ELBOW" RESULTING IN FREQUENT ACCIDENTAL DISCONNECTIONS OF THE CIRCUIT. THE FACILITY STATES, "THIS IS RESULTING IN AN OCCUPATIONAL HAZARD OF INCREASED ANESTHETIC VAPOR EXPOSURE TO PROVIDERS AS WELL AS PLACING THE PATIENTS AT POTENTIAL RISK OF HYPOXIA AND HYPOVENTILATION." THE REPORTER ALSO STATED THAT THE DISCONNECTION CAUSES A PROLONGATION OF THE INDUCTION. NO FURTHER ADVERSE HEALTH OUTCOMES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792129 PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other