MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL TEMP PUMP PROFESSIONAL; PACK, HOT OR COLD, WATER CIRCULATING

Catalog Number	TP700
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that while possibly using atp700 to warm a patient, the patient became visibly burned.The burn allegedly resembled the "honeycomb" pattern of the blanket/pads.
Additional Manufacturer Narrative
The user facility stated that the t-pump was used with either a large or small rapr-round kit and that they did have lot numbers of the wraps that had been used.It was reported that the patient injury was classified as a minimal temporary harm.The injury was evaluated by a wound care consult who evaluated the patient approximately 31 hours after discovery.No treatment was deemed necessary for this patient.Allegedly blisters were observed throughout the patient's mid back and the top layer of skin was sloughing.The product was scrapped before an evaluation could take place.Although the product was not available for further evaluation, it could not be confirmed if this unit met specifications.Based on a conversation with a stryker associate engineering manager, this issue may be attributed to both the primary and backup limit thermostats experiencing a failure.It was identified by a stryker quality assurance engineer that for a burn to occur, the product would need to be greater than 44°c.Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42°c.As such, this issue could not have occurred without a failure of both the primary and backup limit thermostats, however this could not be confirmed.Device not returned.
Event or Problem Description
It was alleged that while possibly using atp700 to warm a patient, the patient became visibly burned.The burn allegedly resembled the "honeycomb" pattern of the blanket/pads.

• Brand Name: CAPITAL TEMP PUMP PROFESSIONAL
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8092186
• Report Number: 0001831750-2018-01439
• Device Sequence Number: 2025362
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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?: Yes
• Operator of Device: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1