MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 70106.7840

Device Problem Improper Chemical Reaction (2952)

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

Event Date 06/21/2020

Event Type  malfunction  

Event Description

Complaint id: (b)(4).Blood oxygen dropping.06/21/20.10:00 - vv ecmo initiated (svo2 79).10:51 - abg - ph 7.41, pco2 50, po2 212, be 6, bicarb 31.4, 100%.11:00 - svo2 63.11:05 - premembrane: ph 7.38, pco2 52, po2 41, be 4, bicarb 30.1, 71%.11:10 - abg - 7.38, pco2 57, po2 251, be 7, bicarb 33.7,100%.11:16 --abg - 7.35, pco2 61, po2 143, be 7, bicarb 33.7, 99%.11:23a -post membrane: ph 7.44, pco2 46, po2 157, be 6, bicarb 31, 99#.11:47a repeat post: 7.36, pco2 58, po2 143, be 5, bicarb 32.5, 99%.12:00 noon - oxygenator change out due to low postmembrane.12:00 - svo2 76, (234 - 191) delta 43.12:40 - premembrane: ph7.35, pco2 58, po2 40, be 5, bicarb 31.9, 67%.12:45 - postmem: ph 7.38, pco2 56, po2 323, be 7, bicarb 33.3, 100%.13:00 svo2 54, (243-201) delta 42.13:08 abg: 7.39, 54, 106, 6, 32.5, 98%.14:00 svo2 56, (251-210) delta 42.Patient was on quadrox for less than 3 hours.Customer would like a return kit and a replacement product!.

Manufacturer Narrative

The device history record was reviewed on 2020-08-06.There were no references found, which are indicating a nonconformance of the product in question.For further investigation the oxygenator was investigated in the laboratory on 2020-08-04.Results of laboratory investigation: the oxygenator was heavily clotted.During visual inspection a crack at the luer connector on the blood inlet side was noticed.The leak test according to lv 201 revealed a leakage from the blood to the gas side.The most probable root cause for the low blood saturation is a deteriorated gas transfer due to a clotted membrane.The clot formation was most likely caused by air in the circuit which entered at the detected leakages.Thus the failure could be confirmed.The occurrence rate was calculated for the reported failure 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 id: (b)(4).

• Brand Name: QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10221050
• MDR Text Key: 203305876
• Report Number: 8010762-2020-00218
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K150267
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: 70106.7840
• Device Lot Number: 70137476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 46 YR