MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 02/14/2014

Event Type  Death  

Event Description

It was reported that a pt was on cardiopulmonary by-pass (cbp) support for six days and had a (b)(4) connected to an oxygenator for temperature management.The perfusionist activated the de-airing cycle of the (b)(4), which is a par of normal operation and circulated cold water through the oxygenator.The acute temperature change resulted in a lethal arrhythmia for the pt.(b)(4).Ref mfr #8010762-2014-0136.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 3694656
• MDR Text Key: 4295788
• Report Number: 3008355164-2014-00054
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2014,02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death