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

Catalog Number TP700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 08/01/2018

Event Type  Injury  

Event Description

The following event was reported via user facility medwatch (b)(4): it was reported that a patient has 2 one centimeter burn wounds presumed to be from the heating pad.One wound is healed and the second is being treated by the wound team.

Manufacturer Narrative

Attempts were made to contact the user facility to gather further information regarding this alleged issue, however, the customer did not respond to these attempts.A review of device functionality and a conversation with a stryker clinical nurse consultant identified that for a burn to occur, the product would need to be greater than 44 degrees celsius.Without a failure of the backup and primary thermostats, the highest temperature the t-pump can reach is 42 degrees celsius.As such, this issue could not have occurred without a failure of both the primary and backup limit thermostats.This could not be confirmed.Device not returned.

Event Description

The following event was reported via user facility medwatch (b)(4): it was reported that a patient has 2 one centimeter burn wounds presumed to be from the heating pad.One wound is healed and the second is being treated by the wound team.

• Brand Name: CAPITAL TEMP PUMP PROFESSIONAL
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7962627
• MDR Text Key: 123677217
• Report Number: 0001831750-2018-01092
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1