MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I HMO AND VHK31000; QUADROX OXYGENATOR WITH RESERVOIR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Event Description

It was reported in the interactive cardio vascular and thoracic advance access published april 4, 2014 that there was a case where there was significant foam formation in the venous reservoir of the maquet quadrox i oxygenator and the vhk 31 00 reservoir system.The pt required maximal suction return causing pressurization of reservoir and foam formation.The pt experienced systemic air embolic which were dealt with by means of retrograde cerebral perfusion and hypothermia with no neurological sequelae.(b)(4).

Manufacturer Narrative

A supplemental medwatch will be submitted if add'l info becomes available.Add'l info: publication- interactive cardiovascular and thoracic advance access published april 4, 2014 (1-3).

• Brand Name: QUADROX-I HMO AND VHK31000
• Type of Device: QUADROX OXYGENATOR WITH RESERVOIR
• 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: janice pevide ; 45 barbour pond drive; wayne, NJ 07470-0000 ; 9737097753
• MDR Report Key: 3827235
• MDR Text Key: 16060815
• Report Number: 3008355164-2014-00101
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2014,04/08/2014

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1