MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SM/M RAPR-ROUND KIT; SYSTEM, THERMAL REGULATING

Catalog Number	8001061550
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were significant leaks in the connectors during connection.When plugging in the warmer set, the leak occurred as soon as it was connected.No defects visible to the naked eye.The users' beds were heavily wet.A complete replacement of the bedding had to be carried out for unstable patients hospitalized in intensive care.No effect on patient health was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.
Event or Problem Description
No new information.

• Brand Name: SM/M RAPR-ROUND KIT
• Common Device Name: SYSTEM, THERMAL REGULATING
• 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: 23990315
• Report Number: 0001831750-2026-00002
• Device Sequence Number: 13361812
• Product Code: DWJ
• UDI-Device Identifier: 57613327175153
• UDI-Public: (01)57613327175153(10)590133
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152266
• 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): 03/31/2026

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 Catalogue Number: 8001061550
• Device Lot Number: 590133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown