MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

Customer reported clogged oxygenator inlet.Abnormally high delta p pressures were noted upon initiation.Number continued to climb higher/faster than normal.Had to switch to a different pedi quadrox-id.(b)(4).

Manufacturer Narrative

The returned product was received by the manufacturer on 2020-02-03.The quadrox-id was investigated in the laboratory on 2020-03-05.Results of laboratory investigation: during the optical inspection of the oxygenator blood deposit on the blood inlet side was found.On the blood outlet side no deposit was found.When rinsing the oxygenator with water, no clotting was detected.The oxy could be rinsed without any problems.A water circuit was established to check the pressure behavior with an external pressure gauge.No increase in pressure could be detected.Why it came to the blockage on the blood inlet side at the customer could not be determined in our laboratory.Further a device history was performed and no references were found, which are indicating a nonconformance of the product in question.Thus the failure could not be confirmed.No root cause could be determined.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9590170
• MDR Text Key: 196070498
• Report Number: 8010762-2020-00017
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
• Device Catalogue Number: 701050330
• Device Lot Number: 70132166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1