MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMAL REGULATING SYSTEM

Model Number INFANT CUREWRAP

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The wraps have not been returned to belmont for evaluation.We have reached out to the hospital to obtain additional information about the case, and to request that the wraps be returned for investigation.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." without additional information, it is difficult to determine what occurred during the case at this time.Should additional information become available, a supplemental report will be submitted.

Event Description

The user facility reported the following: "we have had to use our criticool machine a few times in the last month.Each time, nursing staff has reported that the cooling wrap was leaking and had to be replaced.Today, two wraps in a row were leaking and required replacement.It is only the area directly under the baby that seems to leak, it is not at a connection point with the hoses that is causing the problem.Lot # m190841 exp 3/25/2024.".

Manufacturer Narrative

The reported incident had occurred five months prior, therefore the wraps in question were not available for investigation and the reported leaks could not be confirmed.A sample of two infant curewraps were removed from production and tested on a criticool system for approximately two hours; no leaks were observed.A review of the manufacturing and leak test records for this lot number indicated no deviations or anomalies.All curewraps are 100% leak tested by the manufacturer prior to releasing for shipment.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." no report of patient harm.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: CRITICOOL
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 9833116
• MDR Text Key: 198688465
• Report Number: 1219702-2020-00027
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: INFANT CUREWRAP
• Device Catalogue Number: 508-03521
• Device Lot Number: M190841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/14/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1