MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC OXYGENATOR

Device Problem Occlusion Within Device (1423)

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

Event Date 08/07/2012

Event Type  Injury  

Event Description

The customer stated that he had changed out two hmod30000 due to clotting within 8 hours of application.The customer stated all coagulation parameters were within normal practice, viz.Act, ptt, antixa, and platelet count.Neither sepsis, dic nor hit were diagnosed.(b)(4).The customer originally reported was for a quantity of 2 for a total of 4 devices.This is device 2 of 4.

• Brand Name: QUADROX-ID PEDIATRIC 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: 4365129
• MDR Text Key: 5232298
• Report Number: 3008355164-2014-00348
• 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: 12/16/2014,08/07/2012

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2012
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention