MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT; DTZ

Device Problem No Flow (2991)

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

Event Date 04/03/2012

Event Type  Injury  

Event Description

The customer stated once the device was hooked up, there was no flow in the oxygenator.They changed it out and used another quadrox and that one worked fine.(b)(4).

• Brand Name: QUADROX-ID ADULT
• Type of Device: DTZ
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt
• 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: 4365353
• MDR Text Key: 5259786
• Report Number: 3008355164-2014-00362
• 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: 12/16/2014,04/10/2012

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2012
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2012
• 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