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

Model Number HMOD-30000

Device Problem Occlusion Within Device (1423)

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

Event Date 05/23/2012

Event Type  Injury  

Event Description

During a customer discussion late on (b)(6) 2012, the customer recalled that they had to switch a quadrox pediatric-id oxygenator due to clotting during a recent use.An incident date was not available.The customer stated that anti-coagulation therapy for this patient had been discontinued several hours prior to the clotting issue developing and the customer does not consider this to be a complaint.The device is not available and the customer has stated that no further information will be made available to maquet.The customer stated that there was not patient injury.(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• 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: 4365329
• MDR Text Key: 5259780
• Report Number: 3008355164-2014-00358
• 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: 12/16/2014,05/23/2012

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: HMOD-30000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2014
• 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