BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WESTMED LLC

    MDR report key: 14597146 · Received June 3, 2022

    Report

    Report Number
    2028807-2022-00015
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 3, 2022
    Manufacturer
    WESTMED LLC
    Product Code
    OFP
    UDI-DI
    00709078008290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPLITTING OF THE TUBE CAUSED THE PATIENT TO BECOME HYPOXIC. BASED ON THIS INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAS BEEN MET.

    Additional Manufacturer Narrative · 0

    THE SPLITTING OF THE TUBE CAUSED THE PATIENT TO BECOME HYPOXIC. BASED ON THIS INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAS BEEN MET. COMPLAINT CONFIRMED WITH THE PHOTOS PROVIDED AND RETURNED GOODS. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE HOSE THAT FEEDS ONE OF THE PLASTIC RESINS INTO THE BLENDER WAS NOT PROPERLY CONNECTED. THIS RESULTED IN AN INCORRECT RATIO OF RESINS, LEADING TO THE TUBING BEING MORE RIGID AND MORE LIKELY TO CRACK. LAB RESULTS CONFIRMED THAT TUBING MANUFACTURED AFTER THE HOSE WAS FIXED WAS THE CORRECT RATIO OF PLASTIC RESINS. WE COMPLETED A HEALTH HAZARD EVALUATION AS PART OF THE RISK ASSESSMENT. THE RISK ASSESSMENT PERFORMED WITH RMA-20030 INDICATED A SEVERITY OF 9. WE INITIATED CAPA-00495 TO ADDRESS THIS ISSUE. WE REVIEWED THE COMPLAINT HISTORY IN OUR QUALITY MANAGEMENT SYSTEM RELATED TO THE AFFECTED PRODUCT FOR THE 24 MONTHS PRECEDING THE EARLIEST COMPLAINT RECEIVED. WE DID NOT RECEIVE ANY COMPLAINT FOR THIS PRODUCT PRECEDING COMPLAINT (B)(4). ALSO, WE ANALYZED THE FREQUENCY OF COMPLAINTS WE HAVE RECEIVED FOR THE CIRCUIT PRODUCT FAMILY. THERE IS NO TRENDING ISSUE FOR THE CIRCUIT PRODUCT FAMILY. WE EMAILED RESOLUTION TO THE CUSTOMER.

    Description of Event or Problem · 0

    SPLITS IN THE TUBING. THIS WAS DISCOVERED AFTER THE PATIENT BECAME HYPOXIC.

    Description of Event or Problem · 0

    SPLITS IN THE TUBING. THIS WAS DISCOVERED AFTER THE PATIENT BECAME HYPOXIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834364 WESTMED LLC 96" ADULT EXP,GSE,PAR WYE,(2)BV,LG.MASK,3LF BAG,3LF BAG,10'X.050" MM GSL, OFP WESTMED LLC 9677 122721T03 00709078008290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other