MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that a patient was put on ecls (extra corporeal life support) at 4pm (b)(6) 2022.The customer noticed blood oozing from lower port of quadrox oxygenator at around 5:30pm.Wiped off blood but more coming.Changed oxygenator and no further blood leak noted.Circuit was set up for 2 weeks-standard practice." complaint id: (b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Manufacturer Narrative

It was reported that a patient was put on ecls (extra corporeal life support) at 4pm (b)(6)2022.The customer noticed blood oozing from lower port of quadrox oxygenator at around 5;30pm.Wiped off blood but more coming.Changed oxygenator and no further blood leak noted.Circuit was set up for 2 weeks-- standard practice." the affected product was technically investigated at the laboratory of the manufacturer.During visual inspection blood residues were detected at the gas outlet of the oxygenator.During a tightness test of the product the reported failure "leakage from gas outlet port" was confirmed.The most probable cause of the detected malfunction was determined to be as follows: -insufficient pur (polyurethane) grouting of mat pack: this allows the fluid to transfer to the outer cover.-fiber detachment in the pur potting: this allows the fluid to leak between the fiber an the pur encapsulation.-fiber damage: this allows fluid to leak trough the oxygenating fiber.Maquet cardiopulmonary initiated a non-conformance process in regards to the detected findings.All further actions and investigations will be performed within this process.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 SMALL ADULT/ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14432798
• MDR Text Key: 292213799
• Report Number: 8010762-2022-00175
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 701067859
• Device Lot Number: 70141329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 76 KG