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

Catalog Number TP700

Device Problems Break (1069); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2013

Event Type  malfunction  

Event Description

It was reported that the unit was found with a hole in the tray assembly that was caused by the magnet rubbing the plastic and allowing for water to fill the tray assembly damaging the pc board.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

(b)(4).

• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3549768
• MDR Text Key: 3979147
• Report Number: 0001831750-2014-00134
• 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
• Report Date: 12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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