MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.; DIFFUSION MEMBRANE OXYGENATOR

Catalog Number 70105.3824

Device Problem Filtration Problem (2941)

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

Event Type  malfunction  

Event Description

The perfusion group has observed unusually high clotting of the bioline coated oxygenator and are collecting data and info regarding the use of these devices.Device was swapped out on these pts.No specific date of occurrence.Add'l info rec'd on (b)(6) 2014, i was able to track down one of the oxygenators that had a clot in it.Due to bad handwriting, i can't tell if it is 70094046 or 70094646.It was on a pt for 4 days and we noticed an increased amount of clot and decided to swap it out.Add'l info rec'd on (b)(6) 2014: there is no other info available from the hospital.They are only reporting the one event where they had to swap out the device which unfortunately is unavailable for investigation.(b)(4).Ref # mfr 8010762-2014-00165.

• Brand Name: BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.
• Type of Device: DIFFUSION MEMBRANE 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: 3738009
• MDR Text Key: 4277876
• Report Number: 3008355164-2014-00071
• Device Sequence Number: 1
• Product Code: DTM
• 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: 03/27/2014,03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 70105.3824
• Device Lot Number: 70094046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2014
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1