MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID AD.O.FIL

Model Number HMOD 70000-USA

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 11/07/2014

Event Type  Death  

Event Description

It was reported that call was received from perfusionist in the operating room with concerns of a post-cardiotomy patient on venous access support with quadroxid and rotaflow.Customer stated the patient's act was greater than 1000 seconds and should they attempt to reverse the heparin? informed perfusionist that was their decision, but if nothing was done, bleeding could occur.Customer called back 45 minutes later and stated they had given protamine and transfusions and were observing a much higher pressure drop across the oxygenator, and asked if they should change it.Suggested that changing is generally done when gas exchange is compromised and/or flow through is affected.Perfusionist stated they had another quadroixid and rotaflow set up available if they needed.Change out did not occur and shortly after this observation, support was withdrawn and patient expired.Customer states she feels strongly the negative outcome was patient related not device related.Oxygenator was disposed of.(b)(4).

Manufacturer Narrative

The device was disposed of by the hospital so a device evaluation will not be possible.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: QUADROX-ID AD.O.FIL
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4337464
• MDR Text Key: 5200601
• Report Number: 3008355164-2014-00305
• 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: 12/08/2014,11/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMOD 70000-USA
• Device Lot Number: 70094045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death