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

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.

• Brand Name: POSEY ECONOMY LIMB HOLDER RESTRAINT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 15064705
• MDR Text Key: 296220944
• Report Number: 15064705
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2510
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 17155 DA
• Patient Sex: Female