MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID

Model Number BEQ-HMOD70000-USA

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Concussion (2192)

Event Date 07/04/2012

Event Type  Injury  

Event Description

An oxygenator started to leak from the arterial outlet while in use.The oxygenator started to spray blood from the side of the outlet.The inlet and outlet were clamped while the unit was changed out.The outlet detached while being changed out.The hospital believes the oxygenator was in use for 2 weeks on a patient who had been on ecmo for 100 plus days.Manufacturer previously submitted initial mfg.Report # 8010762-2012-00029.(b)(4).

• Brand Name: QUADROX-ID
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365123
• MDR Text Key: 5240290
• Report Number: 3008355164-2014-00318
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 12/16/2014,07/06/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701053824
• Device Lot Number: 70079206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention