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

Model Number 2510

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ventilator Dependent (2395); Loss of consciousness (2418); Irritability (2421)

Event Date 06/17/2022

Event Type  Death  

Event Description

We received an fda medwatch indicating that a patient who was 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 from an agitated state.The patient was transferred to the 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.The patient was transferred out of the icu.The patient was 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.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.The product was not saved and is unable to be returned for inspection.No lot number or gtin is available.

Manufacturer Narrative

This report is based solely on the information provided by the customer.It was reported that the patient was found deceased while in use with part 2510 posey soft limb holder.The patient was reported as agitated, crying and yanking to pull out the tracheostomy tube.While in the icu, the wrist restraints were applied to the patient since patient had removed the trach tube multiple times.The right restraint was removed from the patient and only the left hand was restrained as the patient had hemiparesis.Customer confirmed restraint had been loosened by patient and patient pulled out tracheostomy tube.The restraint was found intact, not torn or broken and the restraint had remained secured to the patient¿s wrist and tied to the bed when the patient was found.Confirmed agitated state with hospital staff thus demonstrating the part 2510 was not right for the patient.Confirmed with hospital staff the patient was left on right side (paralyzed side) and the nurse left the room.When the nurse came came back into the patient room the patient was on her back had removed her trach tube and had expired.The patient's left arm restraint was tight (non-paralyzed arm) and when positioned on the right side of body in the bed; but when she moved to her back, there would be some slack to that left restraint that allowed her access to the tracheostomy tube.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu contraindications state do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.The warnings state additional or different body or limb restraints may be needed (visit tidiproducts.Com): 1.If the patient pulls violently against the bed straps, 2.To reduce the risk of the patient getting access to the line/wound/tube site.3.To prevent the patient from flailing or bucking up and down and causing self-injury.Application instruction warnings state: failure to complete every step of the application instructions may result in product failure or breakage.Step 5 and 6 state: check to make sure the strap cannot slide in any direction or loosen if the patient pulls on it, or if the bed is adjusted.Adjust the bed strap(s) to allow desired freedom of movement, without compromising patient or caregiver safety.A lot number was not provided so manufacturing records could not be reviewed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.The adverse event investigation is on going, and the results of this investigation will be provided in a supplemental.This report is in response to fda mdr 24000100000-2022-8025.Mdr 2400010000-2022-8025 / manufacturer reference file (b)(4).

Event Description

Supplemental report being provided to report additional investigation results.

Manufacturer Narrative

This report is based solely on the information provided by the customer -(b)(6).The customer requested investigation assistance from mha (minnesota hospital association) on determining root cause for this incident.The mha registry advisory committee reviewed the facts of the case provided by (b)(6) hospital.This is an excerpt of the results of the mha investigation provided to tidi by (b)(6) hospital:.The mha registry advisory committee meeting was moved to this tuesday, the 30th.The group had reviewed the facts of this case anonymously via email and then requested more discussion in their meeting as it was a very challenging case for the committee, like it was for us.We discussed at length today around proper/improper use of restraints as well as the device event, we tediously reviewed the mha recommendations and guidance document and how the wording is phrased (just like we do in determination meetings).This document is used to give guidance to hospitals across the state in order for consistency around reporting of adverse events.A continuation of the north memorial investigation conclusion.After a lot of discussion, the committee ultimately went to not-reportable.From the discussion, they found opportunity to give clarity in the document around what does lack of and improper use mean, that way it can give more clarity to hospitals.But the intent of that portion of the reportable event is more around restraint tied to wrong part of bed, wrong restraint device used against order, not used per manufacturer instructions, etc.A continuation of the north memorial investigation conclusion.They all agreed, yes an adverse event happened and we have thoroughly reviewed a sad, difficult and challenging case, and we have a correction action plan in place from our learning.An internal tidi engineering investigation test was performed to confirm proper functioning of the device (part#2510) strapped to a hospital bed.Installation of the device was performed following the instructions in the ifu pn: i9211 rev.C.For the part# 2510 (economy limb holder) with sample taken from lot # 2103t290, the product was used on a hospital bed (hill-rom versacare).In order to perform the evaluation, the knot section of the restraint was marked with black ink to allow evaluation of the knot after aggressively pulling on the restraint in different instances, directions and forces (by an adult male - video available upon request).The reported issue was not confirmed in this test; the evaluation found there was little to no loosening (movement from the black marks) observed of the knot on the anchor point of the bed.The restraint remained intact after aggressive behavior.The aggressive and agitated state that was reported in the original medwatch for this patient supports the probable cause that the right device was not used on the patient.The ifu contraindications state.Do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.The warnings state.Additional or different body or limb restraints may be needed (visit tidiproducts.Com): 1.If the patient pulls violently against the bed straps, 2.To reduce the risk of the patient getting access to the line/wound/tube site.3.To prevent the patient from flailing or bucking up and down and causing self-injury.There is no manufacturing malfunction confirmed, nor is there corrective action required as a result of this adverse event.Fda mdr (b)(4) / manufacturer reference file (b)(4).H3 other text : product discarded.

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15250684
• MDR Text Key: 298152653
• Report Number: 2182318-2022-00102
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676005298
• UDI-Public: 10190676005298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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
• Device Catalogue Number: 2510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 47 YR
• Patient Sex: Female