MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Insufficient Information (3190)

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

Event Type  No Answer Provided  

Manufacturer Narrative

Update 03/16/2016 09:48 am (gmt-4:00) (b)(4): per (b)(4) the device was evaluated by a (b)(4) technician and the problem was not reproducible.There are no error codes in the error log.The primary temperature probe was replaced with the secondary temperature sensor on the patient side.Functional testing was performed and the device was returned to service.(b)(4).

Event Description

Update 03/16/2016 09:41 am (gmt-4:00) (b)(4): this is a supplemental for the original paper record that was submitted may 29,2014.Mfg report # 8010762-2014-00218 (b)(4).

• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5503797
• MDR Text Key: 40801004
• Report Number: 8010762-2016-00183
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1