MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER; QUADROX-I ADULT OXYGENATOR

Model Number BE-01970311-PLS

Device Problems Restricted Flow rate (1248); Filtration Problem (2941)

Patient Problem Myocardial Infarction (1969)

Event Date 09/06/2014

Event Type  Injury  

Event Description

It was reported that while initiating ecmo (extra corporeal membrane oxygenation) with a second device, the flow would not exceed 500 ml/min.The ecmo lines were noted to be clotted despite controlled anticoagulation.The device was replaced.During this event, the pt suffered a heart attack and had to be resuscitated.Two days later the pt resides in intensive care.(b)(4).

Manufacturer Narrative

The investigation is still pending.A supplemental medwatch will be submitted when additional info becomes available.This report is related to medwatch report # 8010762-2014-00781 and 8010762-2014-00782 and 7010762-2014-00788.

• Brand Name: BE-01970311-PLS#D-QUADROX-I ADU.O.FILTER
• Type of Device: QUADROX-I ADULT OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229732113
• MDR Report Key: 4162721
• MDR Text Key: 4786230
• Report Number: 8010762-2014-00789
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2014

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: 09/25/2014
• Device Model Number: BE-01970311-PLS
• Device Catalogue Number: 70105.0758
• Device Lot Number: 70098205
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention