BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRI TRANSPORT CIRCUIT

    MDR report key: 3874457 · Received May 25, 2014

    Report

    Report Number
    2028807-2014-00002
    Event Type
    Death
    Date Received
    May 25, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 25, 2014
    Product Code
    CAI
    PMA / PMN Number
    K923618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MANY DISCREPANCIES REPORTED BY (B)(6): ON (B)(6), SHE REPORTED THAT ALL THE TUBING WERE UNATTACHED FROM THE PEEP VALVE AND THAT NOTHING WAS INCORRECTLY ASSEMBLED BY WESTMED; ON (B)(6), CONFIRMED THAT 10 CIRCUITS WERE CONNECTED INCORRECTLY WITHIN THE PACKAGE; ON (B)(6), SHE SAID TWO OR THREE MRI CIRCUITS WHICH WERE CONNECTED INCORRECTLY WITHIN THE PACKAGE, WERE USED ON PATIENTS AND SHE HAD AN ADD'L THREE MRI CIRCUITS WHICH WERE ALSO CONNECTED INCORRECTLY. THEREFORE, THE NUMBER OF INCORRECTLY CONNECTED MRI CIRCUITS WOULD BE FIVE (5) OR SIX (6), NOT TEN (10), AS SHE HAD STATED ON (B)(6) 2014. OUR INTERNAL INVESTIGATIONS SUPPORT OUR CONCLUSION THAT ALL MRI CIRCUITS PART NUMBER 9317 MANUFACTURED, INCLUDING THE 08272013001, WERE ASSEMBLED AND SHIPPED CORRECTLY FROM WESTMED. IT APPEARS THAT THE PRODUCT SHOWN BY (B)(6) WITH THE TUBING ATTACHED INCORRECTLY WAS A RESULT OF SOMEBODY ATTACHING THE TUBING WITHOUT OPENING THE POLYBAG WHICH WAS SEALED AT WESTMED AND INADVERTENTLY ATTACHED IT INCORRECTLY AT THE HOSP. WESTMED'S CONCLUSION IS THAT THE TWO PT INCIDENTS HAPPENED DUE TO USER ERROR. THE STATEMENT FROM (B)(6) THAT THIS PROBLEM HAD OCCURRED ON TWO (2) DIFFERENT VENTILATOR SUPPORTED, CRITICALLY ILL PATIENTS DURING TRANSPORT, DUE TO A MISCONFIGURED MRI CIRCUIT, WHERE THE RESPIRATORY THERAPISTS RESPONSIBILITY IS TO PROPERLY CONNECT THE CRITICALLY ILL PT TO THE TRANSPORT VENTILATOR AND MONITOR VITAL SIGNS DURING THE TRANSPORT IS VERY DIFFICULT TO BELIEVE FOR THE FOLLOWING REASONS: THE RESPIRATORY THERAPISTS HAD BEEN USING THIS PRODUCT FOR 2 1/2 MONTHS AND WERE REQUIRED TO ATTACH THE CORRUGATED TUBE TO THE VENTILATOR TUBE ON THE MANIFOLD AND THE ET TUBE AT THE PT END OF THE MANIFOLD EACH TIME THEY USED THE PRODUCT. THE RESPIRATORY THERAPIST WOULD IMMEDIATELY SEE THE PRODUCT WITHIN THE OUTER WRAP AND RECOGNIZE IT WAS DIFFERENT THAN WHAT THEY WERE USING FOR THE PAST 2 1/2 MONTHS; THE HOSP WOULD ONLY TRANSPORT ONE CRITICALLY ILL VENTILATOR SUPPORTED PT AT A TIME.

    Description of Event or Problem · 1

    ON (B)(4) 2014 (B)(4), RECEIVED A PHONE CALL FROM (B)(6) STATING THAT THE CIRCUIT P/N 9317, LOT # 08272013001 WAS NOT ASSEMBLED AND THAT IT WAS DANGEROUS UNLESS A VERY SAVVY CLINICIAN WAS AVAILABLE TO ATTACH THE TUBING END OF THE ASSEMBLY AND NOT THE END THAT CONNECTS TO THE PORTABLE VENTILATOR. ON (B)(6) 2014 (B)(6) STATED THAT THEY HAD PURCHASED 4 CASES (10 EACH/CASE) OF THE WESTMED MRI CIRCUITS (P/N 9317). OF THE 40 MRI CIRCUITS PURCHASED, THE HOSP HAD USED 20 CIRCUITS AND FOUND THAT AN ADD'L 10 CIRCUITS WERE CONNECTED INCORRECTLY WITHIN THE PACKAGE (I.E.) THE CORRUGATED TUBING WAS CONNECTED TO THE PT CONNECTION OF THE MANIFOLD INSTEAD OF CONNECTING TO THE TUBING CONNECTION. ON (B)(4) 2014 (B)(4) MET WITH (B)(6) AND WHEN SHE WAS ASKED IF SHE THOUGHT IT WAS POSSIBLE FOR SOMEONE IN THE HOSPITAL WITH GOOD INTENTIONS TO SAVE TIME PRIOR TO PT USE TO ATTACH THE CIRCUIT AND VALVE WHILE IT REMAINS IN THE PACKAGING, SHE RESPONDED, "I DON'T HAVE A CRYSTAL BALL BUT I GUESS THAT COULD HAVE HAPPENED." SHE SAID TWO OR THREE MRI CIRCUITS WHICH WERE CONNECTED INCORRECTLY WITHIN THE PACKAGE, WERE USED ON PATIENTS AND SHE HAD AN ADD'L THREE MRI CIRCUITS WHICH WERE ALSO CONNECTED INCORRECTLY. THEREFORE THE NUMBER OF INCORRECTLY CONNECTED MRI CIRCUITS WOULD BE FIVE (5) OR SIX (6), NOT TEN (10), AS SHE HAD STATED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309893 MRI TRANSPORT CIRCUIT NONE CAI 9317 08272013401

    Patients

    Seq Age Sex Outcome Treatment
    1 Death