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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS, LLC POSEY ECONOMY LIMB HOLDER RESTRAINT RESTRAINT, PROTECTIVE

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TIDI PRODUCTS, LLC POSEY ECONOMY LIMB HOLDER RESTRAINT RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2510
Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Patient Problems Emotional Changes (1831); Paresis (1998); Loss of consciousness (2418); Irritability (2421); Unintended Extubation (4564)
Event Date 06/17/2022
Event Type  Death  
Event Description
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.
 
Event Description
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.
 
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Brand NamePOSEY ECONOMY LIMB HOLDER RESTRAINT
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
TIDI PRODUCTS, LLC
570 enterprise dr
neenah WI 54956
MDR Report Key15064705
MDR Text Key296220944
Report Number15064705
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2022,07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number2510
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/15/2022
Event Location Hospital
Date Report to Manufacturer07/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2022 Patient Sequence Number: 1
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