MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC OXYGENATOR

Device Problem Occlusion Within Device (1423)

Patient Problem Sepsis (2067)

Event Date 09/28/2012

Event Type  Injury  

Event Description

Oxygenator developed clots and failed to work.Had to be changed out four times.(b)(6) unstable during change out.Patient e-coil sepsis.(b)(4).The customer reported it changed out the unit 4 times.This is device 3 of 4.

• Brand Name: QUADROX-ID PEDIATRIC OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 4365104
• MDR Text Key: 16558293
• Report Number: 3008355164-2014-00375
• 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: 12/17/2014,10/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2012
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention