MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VEMO 31000-USA-QUADROX-I; QUADROX OXYGENATOR

Model Number VKMO 31000

Device Problem Filtration Problem (2941)

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

Event Date 02/10/2014

Event Type  Injury  

Event Description

It was reported that while supporting a pt on cpb (cardio pulmonary bypass), the stop-cock on the venous reservoir was opened to administer drugs and blood spurted out of the reservoir.Blood and foam continued to rise out of the reservoir, causing the port to be capped and unused.During this period, two pump suckers and two vents were running into the reservoir.No reported pt effect.(b)(4).

• Brand Name: VEMO 31000-USA-QUADROX-I
• Type of Device: QUADROX 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: 3812030
• MDR Text Key: 4368939
• Report Number: 3008355164-2014-00093
• 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: 04/25/2014,03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2014
• Device Model Number: VKMO 31000
• Device Catalogue Number: 70105.5116
• Device Lot Number: 70077962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 14