BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANESTHESIA CIRCUIT

    MDR report key: 1667651 · Received April 23, 2010

    Report

    Report Number
    9710644-2010-00001
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 23, 2010
    Manufacturer
    WESTMED, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WESTMED PERFORMED A THOROUGH REVIEW OF ALL CUFFS IN STOCK THAT INCLUDED AN INSPECTION OF NEARLY (B) (4) CUFFS WITH NO OCCLUSIONS FOUND. (B) (4). MFG RECORDS AND MAINTENANCE LOGS WERE REVIEWED TO DETERMINE POSSIBLE ROOT CAUSES FOR THE OCCLUSION. RECORDS DO NOT INDICATE ANYTHING OUT OF THE ORDINARY ASSOCIATED WITH THE LOTS IN STOCK AT THE HOSP. FOR THIS REASON, WESTMED BELIEVES THAT THE OCCLUSION EXPERIENCED WAS AN ISOLATED INCIDENT AND NOT A SYSTEMIC ISSUE. CURRENT CONTROLS IN PLACE INCLUDE DIMENSIONAL AND VISUAL QUALITY INSPECTIONS CONDUCTED AT AN APPROPRIATE SAMPLING LEVEL. AN ADDITIONAL INSPECTION EVERY 15 MINUTES INVOLVES EACH PIECE IN A SINGLE SHOT INSPECTED BY BEING DROPPED OVER A POLE TO ENSURE THERE ARE NO OCCLUSIONS. ALSO, AFTER FINAL PRODUCT ASSEMBLY, EACH CIRCUIT IS 100% FLOW TESTED. THE TEST IN PLACE WILL ONLY DETECT FULL OCCLUSIONS WHERE THERE ARE NO HOLES AT ALL IN THE AIRWAY. PER CONVERSATION WITH USER FACILITY ON 4/16/2010, THE CUFF CONTAINING THE DEFECT HAD HOLES IN THE LAYER OF FLASH WHICH WOULD ALLOW SOME AIR THROUGH. THE CURRENT TEST ONLY ALLOWS FOR THE DETECTION OF TOTAL NO FLOW SITUATIONS. AS A RESULT OF THE INCIDENT AT THE FACILITY, AN ADDITIONAL MFG STEP HAS BEEN ADDED THAT REQUIRES THE OPERATOR TO PLACE THE CUFF OVER A ROD FIXTURE PRIOR TO ASSEMBLE. THE ROD ENSURES THAT EACH CUFF IS FREE OF ANY FLASH THAT MAY BE BLOCKING THE AIRWAY. THIS CHECK ADDS A LEVEL OF REDUNDANCY TO THE QUALITY CHECKS ALREADY IN PLACE. IT ALSO FURTHER ENSURES THAT PIECES THAT MAY APPEAR TO BE TOTALLY FLASHED OVER BUT CONTAIN SMALL HOLES, WHICH WOULD PASS THE CURRENT OCCLUSION TEST BECAUSE THEY ALLOW SOME AIRFLOW, ARE IMMEDIATELY IDENTIFIED, REMOVED, AND THE CONDITION ELEVATED TO MGMT. FURTHER IMPROVEMENTS TO THE TEST METHOD ARE BEING INVESTIGATED TO DETECT PARTIAL OCCLUSIONS. THE INSTRUCTIONS FOR USE FOR THIS CIRCUIT INDICATE "PRIOR TO PATIENT CONNECTION: CHECK THAT ALL CONNECTIONS ARE SECURE. FULLY EXTEND THE TUBING (IF USING EXPANDABLE CIRCUIT). PRESSURIZE TO ENSURE THERE IS NO LEAKAGE OR OCCLUSION OF THE CIRCUIT." THE USER FACILITY DID NOT CONDUCT THE INDICATED SETUP CHECKS PRIOR TO PT USE.

    Description of Event or Problem · 1

    CUFF GOING INTO EXPANDABLE TUBING WAS OCCLUDED. THIS RESULTED IN PT HAVING CARDIAC ARREST, PT WAS REVIVED VIA CPR. SURGERY HAD TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANESTHESIA CIRCUIT CAI WESTMED, INC. 9050 EXACT LOT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention