MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC COOLING TOWER

Model Number HCU 30

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 05/01/2017

Event Type  Death  

Event Description

Patient with cystic fibrosis and ischemic brain injury on ecmo.While being turned, ecmo alarm sounded and nurse noted circuit displayed temperature <35.0.The cooler tower was immediately unplugged but patient became bradycardiac and arrested.She was resuscitated but overall prognosis extremely poor and on (b)(6)2017 life support was withdrawn and the patient expired.

• Brand Name: COOLING TOWER
• Type of Device: COOLING TOWER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 6639497
• MDR Text Key: 77534287
• Report Number: 6639497
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HCU 30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Distributor Facility Aware Date: 05/01/2017
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29 YR