MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-D ADULT OXYGENATOR

Model Number BEQ HMOD 70000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/16/2012

Event Type  Injury  

Event Description

Customer reported, "had problem with an outlet on a quadrox -d- adult oxygenator.Changed out while the patient was on ecmo.No reported problem to the patient".Tom did not know how long the patient was on ecmo, nor did he know the lot # of the device.(b)(4).

• Brand Name: QUADROX-D ADULT OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4365349
• MDR Text Key: 5259785
• Report Number: 3008355164-2014-00351
• 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
• Type of Report: Initial
• Report Date: 12/16/2014,05/16/2012

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 HMOD 70000
• Device Lot Number: 70077518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2012
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2012
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention