MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HMOD 70000-USA#QUADROX-ID ADULT; DIFFUSION MEMBRANE OXYGENATOR

Catalog Number 70105.3815

Device Problems Coagulation in Device or Device Ingredient (1096); Filtration Problem (2941)

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

Event Date 04/18/2014

Event Type  Injury  

Event Description

It was reported that an oxygenator had to be changed less than 24 hours into the run.Anti-xa, aptt, teg, atiii levels along with act, platelet count and fibrinogen levels were being observed.All appeared fine when a clot on the oxy side (arterial side) rapidly appeared.No injury to the patient was reported.(b)(4).Reference mfr # 8010762-2014-00208.

• Brand Name: HMOD 70000-USA#QUADROX-ID ADULT
• 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: 3870166
• MDR Text Key: 19800072
• Report Number: 3008355164-2014-00103
• 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: 05/21/2014,04/21/2014

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 Expiration Date: 09/18/2015
• Device Catalogue Number: 70105.3815
• Device Lot Number: 70093818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO
• Patient Weight: 4