MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that a red tinged drop of condensate has exited the gas exhaust port of the pediatric quadrox id.There is no negative patient sequalae due to this event.The oxygenator was not changed out due to this event.Oxygenator continues to function as normal.Customer informed me that the oxygenator was exposed to line pressures around 320 mmhg, however the pressure drop across the membrane was approximately 20 mmhg.No harm to any person was reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a red tinged drop of condensate has exited the gas exhaust port of the pediatric quadrox id.There is no negative patient sequelae due to this event.The oxygenator was not changed out due to this event.Oxygenator continues to function as normal.Customer informed me that the oxygenator was exposed to line pressures around 320 mmhg, however the pressure drop across the membrane was approximately 20 mmhg.No harm to any person was reported.The affected product was not available for technical investigation of the manufacturer.The reported failure "leakage at the gas outlet" was not investigated in a previous complaint yet.Thus the exact root cause of the reported failure is unknown.The production records of the affected oxygenator (batch 3000194747 / 3000191462) were reviewed on 2022-01-10.Following steps are performed according to the bop with a 100 % inspection: tightness check blood side, tightness check water side, and final product check.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Therefore it was not possible to confirm the reported failure "leakage at the gas outlet".However, according to our risk management the following most probable causes could be associated with the reported failure: broken fibers and diffusive fiber delamination.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.H3 other text : 4115.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID PEDIATRIC
• 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: 13041849
• MDR Text Key: 282482604
• Report Number: 8010762-2021-00663
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100278
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 701070397
• Device Lot Number: 3000194747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1