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

Model Number QUADROX-I NEONATAL/PEDIATRIC

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the complaint definition; ''the customer stopped bypass after surgery (after 118 minutes), and did go on modified ultra filtration (muf) mode.After 6-7 minutes they needed to go back on bypass because the patient was not doing very well.When they were trying to get back on bypass there was a plasma leak from the yellow cap on the oxy, and there was no blood volume going through the oxy.They needed to do an oxy change-out.Patient did not receive any protein suppletion yet.'' complaint #: (b)(4).

Manufacturer Narrative

It was reported that there was a plasma leak from the yellow cap on the oxygenator and there was no blood flow going through the oxygenator.They needed to do an oxygenator change-out.The product has been investigated by getinge laboratory on 2021-02-16.No abnormalities or damage could be found.Leak test for the blood side was performed.No leaks could be found here.Furthermore, a tightness test for the water side was carried out, with no pressure drop occurring after 10 minutes and no leaks being found.The tests carried out did not reveal any abnormalities in the oxygenator.Therefore, the product problem cannot be confirmed by the laboratory.Device history record for lot 92306510 and lot 70140714 were reviewed on 2020-11-19.There is no evidence indicating non-conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Furthermore , a medical assessment was performed by medical affairs specialist on 2021-02-16.Results of medical assessment: the conclusion of the product investigation revealed no abnormalities in the oxygenator.Therefore, a root cause, which contributed to the issue the complaint outlines, cannot be determined.However, it is possible that the modified ultra filtration (muf) procedure may have created an environment that allowed unexpected clotting even though no clots were identified in the extracorporeal circuit.The average weight of heparin is 9000-12000 daltons.The average sieving weight for hemofilters is 65,000 daltons.It is possible that heparin may have been removed by the hemofilter which allowed clotting to occur.The information obtained so far in this investigation would confirm that the device met its specification at the time of use.Since there is no product related problem, the failure could not be confirmed.According to the risk management file of the product the probable root cause could be: the user does not recirculate blood in case of interruption in or ended perfusion coagulation / clotting pressure exceeds tightness level of de-airing ports leakage at de-airing port the occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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: #(b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10910609
• MDR Text Key: 218576275
• Report Number: 8010762-2020-00404
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: QUADROX-I NEONATAL/PEDIATRIC
• Device Catalogue Number: 70107.0374
• Device Lot Number: 70140714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1