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

Catalog Number TP700

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 01/23/2016

Event Type  malfunction  

Event Description

It was reported in report reference number mw5060036 that the heating pad was applied directly to the skin.Nursing noted redness and blistering consistent with heating pad pattern.

Manufacturer Narrative

It was reported by the customer that the patient had redness and blistering on the skin after using a t/pump.The alleged event did not require any treatment or medical intervention.The event was reported to have occurred using one of two devices, however, the customer could not identify which unit was involved in the alleged event.The customer did not report or allege any device defect or malfunction.It was reported that the nursing staff did not check the patient's skin every 30 min as recommended in the manual and the alleged injury was likely a result of failing to perform the recommended skin checks.The customer reported that the staff will be trained to check the patient¿s skin at least every 30 minutes as stated in the product manual.The device was not returned for evaluation.

Event Description

It was reported in report reference number mw5060036 that the heating pad was applied directly to the skin.Nursing noted redness and blistering consistent with heating pad pattern.

• 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: 5511117
• MDR Text Key: 40700152
• Report Number: 0001831750-2016-00098
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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