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

Model Number BE-HMOD 30000#BE-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 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Thrombosis on the venous side of two be-hmod 30000 oxygenators , with the same batch number, used in the same patient consecutively in the hospital la paz, in madrid.One of them lasted 31 hours on (b)(6) 2020, and the other 13 hours on (b)(6) 2020.It had to be changed for another oxygenator, from a different batch, and no more problems were reported.Complaint #: (b)(4).

Event Description

Complaint # (b)(4).

Manufacturer Narrative

Second oxygenator with thrombosis on the venous side of the oxygenator after 13 hours of use with the same neonate was reported.Maquet cardiopulmonary requested the product in question for further investigation in the laboratory of the manufacturer on 2020-09-25.The returned product was received by the manufacturer on 2020-10-08.The 2 quadrox-id were investigated in the laboratory on 2021-01-15 with following results (refer file attachment).During cleaning according to lv 205 revealed massive contamination in oxygenator 1.Oxygenator 1 was so heavily clotted that a low water flow was only possible with a very high pressure increase.Oxygenator 1 was then cleaned with sodium hydrochloride.This process was repeated 7 times, resulting in the cleaning of this oxy over several days.Oxygenator 2 was only slightly contaminated.No clots could be detected.The leak test of the water side according to lv 202 showed no pressure drop in both oxygenators.The leak test of the blood side according to lv 201 showed a pressure drop of approx.¿p=0.4 bar after 300 minutes for oxygenator 1 and 2.No water leakage could be observed from the oxygenators on the blood side during both leak tests.With reference to the risk assessment quadrox-id pediatric, dms # 1462367, v18) and in consultation with the manager medical affairs the following events can contribute to clotting in the circuit: -de-airing luer lock connection too loose -air remains in or enters the circuit -debris formation (clogging) at the inlet fiber structure of the oxygenator -hemodynamic impairment -hemostasis -insufficient anticoagulation, occlusion of the extracorporeal circulation -act too low for specific procedure and patient condition based on this the reported failure could be confirmed but no product related malfunction.The production records of the affected quadrox-id päd.O.Filt.(dms# 2926276 and dms #2926275) were reviewed on 2021-01-19.Following tests are performed according to the bop as a 100 % inspection: ¿ leak test after welding ¿ pressure test heat exchanger ¿ leak test water side ¿ leak and flow test gas side ¿ pressure test blood side ¿ coating test according to the final test results, the oxygenator with the serial #1491679 and # 1491798 passed the test as per specifications.Production related influences can be excluded.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident 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.

• 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: 10580697
• MDR Text Key: 208355018
• Report Number: 8010762-2020-00312
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 70104.7041
• Device Lot Number: 70134792
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3