BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON DUAL LIMB HEATED CIRCUIT

    MDR report key: 2234230 · Received August 22, 2011

    Report

    Report Number
    3004365956-2011-00315
    Event Type
    Death
    Date Received
    August 22, 2011
    Date of Event
    May 5, 2011
    Report Date
    August 1, 2011
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MFR IN TIME FOR THIS REPORT. INVESTIGATION INCOMPLETE. A COMPLETED INVESTIGATION REPORT WILL BE SUBMITTED WHEN COMPLETED.

    Description of Event or Problem · 1

    A (B)(6) OLD PT EXTUBATED EARLY IN THE DAY FOR A TRIAL OFF THE VENTILATOR. PT UNABLE TO BE MAINTAINED WITH INCREASING RESPIRATORY EFFORT. DECISION MADE TO REINTUBATE AND PLACE BACK ON THE VENTILATOR. SEDATION AND REINTUBATION PROCESS WENT SMOOTHLY. IMMEDIATELY AFTER, X-RAY WAS DONE TO VERIFY TUBE PLACEMENT. THIS WAS OUT OF SEQUENCE AS USUALLY THE RESPIRATORY TECH WOULD HAVE FINISHED ALL CHECKS PRIOR TO THE X-RAY. AT 17:08 PT WAS INTUBATED. THE NURSE AT THE DESK NOTED ON THE MONITOR THAT THE PT'S HEART HAD SLOWED AT APPROX 17:17 AND CALLED OUT TO ALERT THE TEAM AND WENT INTO THE PT'S ROOM. NO ALARM HAD SOUNDED. THE PT WAS RAPIDLY TAKEN OFF THE VENT AND BAGGING WAS BEGUN. MEDICATION WAS GIVEN BUT NO COMPRESSION WAS DONE AS PT HAD A DO NOT RESUSCITATE ORDER ON FILE. DEATH WAS PRONOUNCED AT 17:37. ACCORDING TO THE HOSPITAL RISK MANAGER, EXAMINATION OF THE SYSTEM FOLLOWING THE INCIDENT REVEALED THAT AFTER CONNECTING THE PT TO THE VENTILATOR, NO ONE NOTICED THE VENTILATOR WAS DISPLAYING #WAITING TO CONNECT#. EXAMINATION OF THE ENTIRE SYSTEM REVEALED THE TEMPERATURE PROBE WAS NOT BEING USED AND THE PORT THAT THE PROBE WAS NORMALLY INSERTED INTO WAS NOT CAPPED. THIS LEFT AN OPEN CIRCUIT. FOR THIS REASON THE VENTILATOR RECOGNIZED THE CONNECTION TO THE PT SO IT NEVER INITIATED THE FIRST BREATH. THE RISK MANAGER READILY ADMITTED THERE WAS USER ERROR FOR BOTH THE VENTILATOR AND THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON DUAL LIMB HEATED CIRCUIT HEATED CIRCUIT BZO TELEFLEX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death VENTILATOR USED WAS FROM ANOTHER MEDICAL| DEVICE COMPANY.