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 Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2020

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for investigation but the product was disposed by the customer.Therefore no laboratory investigation could be performed by the manufacturer.Two pictures were attached to the complaint showing a clot on the arterial / outlet side of the oxygenator.On (b)(6) 2020 the customer stated that they "don't believe it was a failure of the oxygenator".Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on the information available at this time, the oxygenator in question operated within mcp specifications.Thus the reported failure could not be confirmed.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The most probable root cause could not 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.The product was disposed by the customer.

Event Description

The customer had a pedi quadrox that came in that developed very large arterial clots and fibrin in less than 24 hours.They disposed of the oxygenator.Additional information was received on 2020-02-04: the oxygenator was replaced during treatment.There wasn't any change in flow rates or pressures across the oxygenator it just formed a very large clot on the arterial side of the oxygenator, which is why the customer chose to change it.They don't believe it was a failure of the oxygenator, it was changed to prevent embolus getting to the patient.(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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9680477
• MDR Text Key: 190537365
• Report Number: 8010762-2020-00053
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Model Number: BEQ-HMOD30000-USA#QUADROX-ID PÄD.O.FILT
• Device Catalogue Number: 701050330
• Device Lot Number: 70133027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1