MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATORS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number OTHER OXYG. OLD QUADROX

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Liquid in the gas line / after priming of the oxygenator hmo 71000 from set bo-hqv 124000 # complete set with quadrox (lot 92276902) complaint no:(b)(4).

Event Description

Complaint: (b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8820330
• MDR Text Key: 152044322
• Report Number: 8010762-2019-00221
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTHER OXYG. OLD QUADROX
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 70123435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Patient Sequence Number: 1