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

Catalog Number TP700

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/28/2016

Event Type  Injury  

Event Description

It was alleged that a patient was burned and the skin blistered during use of the device.Further information has not been provided.

Manufacturer Narrative

This report was originally reported in mw5062045.It was reported that the patient had slept on the pad of the tpump all night and when the patient awoke they allegedly had blisters on their bottom.No details of the blisters were provided.It was reported that bacitracin ointment was used to treat the patient's skin.It was identified that the nursing staff only checked on the patient at the beginning of their shift.It is identified in the device operations manual to always check the patients' skin for adverse reactions every 30 minutes or as directed by the physician.A visual and functional inspection was allegedly performed by a representatives of the user facility with the device being powered on for over a 72 hour period.The results of their evaluation found that the tp700 unit was functioning to specification and that no defects could be found with the unit.The unit was then returned to stryker for a visual and functional evaluation as specified in the tp700 service manual by stryker quality technicians.It was found that the device functioned to specification and that no defect could be found.It was confirmed that the unit would not exceed the specified high temperature.The customer agreed with this conclusion and has made plans to do an internal follow-up within their organization.Therefore, to resolve this issue for the customer, it was recommended that they check the patients' skin every 30 minutes or as directed by a physician as instructed in the operations manual.

Event Description

It was alleged that a patient was burned and the skin blistered during use of the device.

• 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: 5676091
• MDR Text Key: 45795917
• Report Number: 0001831750-2016-00176
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

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
• Device Operator: No Information
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1