MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-I ADULT OHNE FILTER ; OXYGENATOR, CARDIOPULMONARY BYPAS

Model Number BE-015703112

Device Problem Filtration Problem (2941)

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

Event Date 08/20/2014

Event Type  Injury  

Event Description

It was reported that during a ecls (extracorporeal life support) run, blood flow was steady at 2.2.Liters/minute.Hemolysis was observed during the entire treatment.The first oxygenator displayed hemolysis and was changed out.The second device was exchanged due to clotting.The third device displayed hemolysis and was also exchanged.It was also reported that when heparin was significantly low due to blood complications, there were issues with oxygenation and ventilation.(b)(4).

Manufacturer Narrative

Investigation still pending.A supplemental medwatch will be submitted when additional info becomes available.This event is related to medwatch report #8010762-2014-01067 and 8010762-2014-01086.Additional information provided-a hls adult tubing set was used for a child, which is not foreseen for use in children.

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The complaint sample was not returned and therefore no evaluation was performed.

• Brand Name: QUADROX-I ADULT OHNE FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPAS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; restatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; restatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4203380
• MDR Text Key: 21932542
• Report Number: 8010762-2014-01087
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,foreign,health pr
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

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 Model Number: BE-015703112
• Device Catalogue Number: 70104.6577
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention
• Patient Age: 11 YR