MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problem Filtration Problem (2941)

Patient Problem Death (1802)

Event Date 07/06/2015

Event Type  Death  

Event Description

It was reported a patient was placed on cardiopulmonary support, post operatively (cabg - coronary artery bypass graft).A non maquet pump reached two liters per minute and then stopped.Unable to regain flow.Patient was cannulated femorally.Perfusionist was not sure why they were not able to maintain flow.(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 0000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 5008197
• MDR Text Key: 23196518
• Report Number: 3008355164-2015-00159
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/14/2015,07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• 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; Required Intervention
• Patient Age: 70 YR