BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSEY ECONOMY LIMB HOLDER RESTRAINT

    MDR report key: 15064705 · Received July 20, 2022

    Report

    Report Number
    15064705
    Event Type
    Death
    Date Received
    July 20, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 8, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS VENTILATOR-DEPENDENT WITH PAST MEDICAL HISTORY OF ACUTE LEFT MCA STROKE WITH RIGHT HEMIPARESIS AND SEVERE APHASIA WAS ADMITTED FROM A TRANSITIONAL CARE FACILITY FOR AGITATION AND CLOSE OBSERVATION. PATIENT SELF-REMOVED THEIR TRACHEOSTOMY TUBE AND STAFF WAS ABLE TO REPLACE TRACH. MEDS WERE ADMINISTERED TO CALM PATIENT DOWN. PATIENT TRANSFERRED TO ICU FOR CLOSE MONITORING WHERE BILATERAL WRIST RESTRAINTS WERE INITIATED AS PATIENT WAS PULLING AT TUBES/TRACH. THE RIGHT RESTRAINT WAS REMOVED DUE TO RIGHT HEMIPARESIS. PATIENT TRANSFERRED OUT OF ICU. PATIENT AGITATED, KICKING, CRYING AND YANKING AT THE RESTRAINT TRYING TO PULL THE TRACH OUT. THE PATIENT WAS REPOSITIONED AND THE RESTRAINT WAS NOTED AS BEING REALLY TIGHT AND THE NURSE HAD RETIED THE RESTRAINT. PATIENT WAS REDIRECTED, REORIENTED, NO LONGER PULLING AT TRACH. RESTING COMFORTABLY IN BED. ORDER WAS PLACED FOR NEW WRIST RESTRAINT AS NURSE RECOGNIZED THE CURRENT RESTRAINT (2050) WAS NOT THE MODEL WE TRANSITIONED TO MONTHS PRIOR--*V2551 WITH THE D RING. WHEN THE REPLACEMENT WRIST RESTRAINT ARRIVED A 2050 MODEL WAS SENT. AT THE TIME OF THE NEXT HOURLY CHECK, THE PATIENT WAS FOUND UNCONSCIOUS, CPR INITIATED AND PATIENT EXPIRED. PATIENT HAD INTENTIONALLY PULLED OUT TRACH. NURSE REPORTED THAT THE RESTRAINT WAS STILL ON THE PATIENT'S WRIST AND WAS TIED TO THE BED WHEN THE PATIENT WAS FOUND. THE RESTRAINT WAS NOT SAVED. POST EVENT REVIEW, THE NURSE REPORTED THAT THE RESTRAINT WAS APPLIED CORRECTLY. THE NURSE WAS ABLE TO DEMONSTRATE CORRECT APPLICATION OF THE RESTRAINT PER THE INSTRUCTIONS FOR USE AND HAD RECEIVED COMPETENCY TRAINING. *VENDOR WAS UNABLE TO FILL ORDER FOR V2551 (NEW VERSION) RESTRAINTS THAT WE HAVE BEEN USING SINCE 2021. THREE CASES OF THE 2050 (OLD VERSION) WERE SUBSTITUTED AND DELIVERED TO CARTS ON THE UNITS WITHOUT GETTING PRIOR APPROVAL FROM NURSING LEADERS, NOR NOTIFICATION OF THE SUBSTITUTION TO NURSING LEADERS WAS MADE. THIS WAS A TEMPORARY SHORTAGE AND ALL 2050 RESTRAINTS HAVE BEEN REMOVED FROM THE CARTS AND REPLACED WITH V2551 RESTRAINTS.

    Description of Event or Problem · 0

    THIS VENTILATOR-DEPENDENT WITH PAST MEDICAL HISTORY OF ACUTE LEFT MCA STROKE WITH RIGHT HEMIPARESIS AND SEVERE APHASIA WAS ADMITTED FROM A TRANSITIONAL CARE FACILITY FOR AGITATION AND CLOSE OBSERVATION. PATIENT SELF-REMOVED THEIR TRACHEOSTOMY TUBE AND STAFF WAS ABLE TO REPLACE TRACH. MEDS WERE ADMINISTERED TO CALM PATIENT DOWN. PATIENT TRANSFERRED TO ICU FOR CLOSE MONITORING WHERE BILATERAL WRIST RESTRAINTS WERE INITIATED AS PATIENT WAS PULLING AT TUBES/TRACH. THE RIGHT RESTRAINT WAS REMOVED DUE TO RIGHT HEMIPARESIS. PATIENT TRANSFERRED OUT OF ICU. PATIENT AGITATED, KICKING, CRYING AND YANKING AT THE RESTRAINT TRYING TO PULL THE TRACH OUT. THE PATIENT WAS REPOSITIONED AND THE RESTRAINT WAS NOTED AS BEING REALLY TIGHT AND THE NURSE HAD RETIED THE RESTRAINT. PATIENT WAS REDIRECTED, REORIENTED, NO LONGER PULLING AT TRACH. RESTING COMFORTABLY IN BED. ORDER WAS PLACED FOR NEW WRIST RESTRAINT AS NURSE RECOGNIZED THE CURRENT RESTRAINT (2510) WAS NOT THE MODEL WE TRANSITIONED TO MONTHS PRIOR--*V2551 WITH THE D RING. WHEN THE REPLACEMENT WRIST RESTRAINT ARRIVED A 2510 MODEL WAS SENT. AT THE TIME OF THE NEXT HOURLY CHECK, THE PATIENT WAS FOUND UNCONSCIOUS, CPR INITIATED AND PATIENT EXPIRED. PATIENT HAD INTENTIONALLY PULLED OUT TRACH. NURSE REPORTED THAT THE RESTRAINT WAS STILL ON THE PATIENT'S WRIST AND WAS TIED TO THE BED WHEN THE PATIENT WAS FOUND. THE RESTRAINT WAS NOT SAVED. POST EVENT REVIEW, THE NURSE REPORTED THAT THE RESTRAINT WAS APPLIED CORRECTLY. THE NURSE WAS ABLE TO DEMONSTRATE CORRECT APPLICATION OF THE RESTRAINT PER THE INSTRUCTIONS FOR USE AND HAD RECEIVED COMPETENCY TRAINING. VENDOR WAS UNABLE TO FILL ORDER FOR V2551 (NEW VERSION) RESTRAINTS THAT WE HAVE BEEN USING SINCE 2021. THREE CASES OF THE 2510 (OLD VERSION) WERE SUBSTITUTED AND DELIVERED TO CARTS ON THE UNITS WITHOUT GETTING PRIOR APPROVAL FROM NURSING LEADERS, NOR NOTIFICATION OF THE SUBSTITUTION TO NURSING LEADERS WAS MADE. THIS WAS A TEMPORARY SHORTAGE AND ALL 2510 RESTRAINTS HAVE BEEN REMOVED FROM THE CARTS AND REPLACED WITH V2551 RESTRAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358160 POSEY ECONOMY LIMB HOLDER RESTRAINT RESTRAINT, PROTECTIVE FMQ TIDI PRODUCTS, LLC 2510

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA Female Death