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

Model Number QUADROX-I SMALL ADULT/ADULT

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that during patient treatment the oxygen saturation decreased.They increased the oxygen concentration with no improvement.After that, they decided to exchanged the quadrox-i during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during patient treatment the oxygen saturation decreased.They increased the oxygen concentration with no improvement.After that, they decided to exchanged the quadrox-i during patient treatment.No harm to any person has been reported.The affected product was investigated at the laboratory of the manufacturer with the following results: no external damage was found during an initial visual inspection of the complaint sample.Since the quadrox-i adult was pre-cleaned and rinsed by customer, no foreign bodies, clots or any clumping could be detected when rinsing.Such contamination could have indicated deterioration or clogging of the lines.In this case, this can no longer be determined retrospectively.A leak test on the blood side was passed.The leak test on the water side was also passed.A final flow test did not reveal any leaks or other irregularities, even when the quadrox-i adult was overloaded.A general functional inoperability of the product can be ruled out.Accordingly, no technical cause of error can be determined for the customer complaint.The production records of the affected oxygenator (batch #3000263480, 3000263748) were reviewed.Following tests are performed as a 100 % inspection: - leak test blood and water side; - coating test ; - final assembly and control.According to the final test results, the oxygenator with the serial# 42656 passed the test as per specifications.Thus a confirmation of the reported failure "oxygen saturation decreased" was not possible.The exact root cause remains unknown.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: OXYGENATOR
• 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: 16528774
• MDR Text Key: 311226254
• Report Number: 8010762-2023-00130
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-I SMALL ADULT/ADULT
• Device Catalogue Number: 701067821
• Device Lot Number: 3000263480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose