MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL BLOOD/FLUID WARMER; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number FW600U

Device Problem Device Inoperable (1663)

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

Event Date 11/18/2013

Event Type  malfunction  

Event Description

It was reported that the unit had damage consistent with melting.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the unit had damage consistent with melting.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

This is a duplicate of mfr report # 0001831750-2014-00126.The serial number (b)(4) and catalog number fw600u reported for this complaint were accidentally submitted into the complaint handling system twice for the exact same complaint instance.Please refer to mfr report # # 0001831750-2014-00126 for full reporting.

• Brand Name: CAPITAL BLOOD/FLUID WARMER
• Type of Device: DEVICE, WARMING. BLOOD AND PLASMA
• 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: 3623914
• MDR Text Key: 4173603
• Report Number: 0001831750-2014-01213
• Device Sequence Number: 1
• Product Code: KZL
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FW600U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• 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