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

Catalog Number	TP700
Health Effect - Clinical Codes	Swelling (2091); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient condition prior to the alleged incident was not disclosed, however, it was identified that there were no pre-existing conditions that would have made the patient susceptible to burns.The patient was immobile during her stay at the hospital and had to have assistance for all meals and movement.The patient had alleged shoulder pain prior to use of the t-pump and a physician ordered heat therapy to be applied but did not indicate the parameters of use.The t-pump was used with a mul-t-pad.The model and lot of the mul-t-pad were not recorded at the time of the event.The t-pump was alleged to be set at 100 degrees f (38 degrees c) and was used continuously with a 20 minute cycle for the night.The patient was put to bed between 17:30-18:30 on march 2nd and was then woken at 7:25 on march 3rd.There were no checks of the patients skin recorded during the time she was put to bed and the time she was awoken.The patient was allegedly diagnosed with a burn wound that was rinsed with sterile saline and had a foam dressing applied.The wound was noted to be closed and healed on march 19th.Information was provided to the user facility that the patient's skin should be checked regularly to ensure the condition is appropriate to continue therapy.
Event or Problem Description
A patient had superficial burns to her back and partial thickness burns to (2) areas with the worst over the left scapula.The patient had wound care provided following the event consisting of xerofoam to blisters with an optifoam gentle dressing.

• 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: 8613538
• Report Number: 0001831750-2019-00566
• Device Sequence Number: 13971728
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 05/15/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1