MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the customer noticed blood on the lower tray below the hls set. Blood seems to be slowly leaking from the venous side of the membrane oxygenator. Otherwise, everything is functioning as it should per customer. The patient is being weaned off support. The patient was ready to come off support regardless of the leak. There was no patient harm, and the patient was weaned off successfully. The patient was covid positive, so the hls disposable was disposed of. The affected product was not available for technical investigation of the manufacturer. Thus the exact root cause of the reported event could not be determined. The production records of the affected hls module (3000159544) were reviewed on 2021-11-22. Following steps are performed according to the bop with a 100 % inspection: tightness test water side, tightness test blood side, final product test. According to the final test results, the oxygenator with the serial# (b)(4) passed the tests as per specifications. No previous complaint with an associated laboratory investigation was found. No picture or video was provided. Thus the reported failure "blood leakage from venous side" could not be confirmed. However the following most probable causes of the reported failure "blood leakage from venous side" are know according to our risk assessment hls set advanced (dms# (b)(4): mechanical damage to the connector during connection, blood tubing is damaged, damaging of connectors during removing of caps. 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

It was reported that the customer noticed blood on the lower tray below the hls set. Blood seems to be slowly leaking from the venous side of the membrane oxygenator. Otherwise, everything is functioning as it should per customer. The patient is being weaned off support. The patient was ready to come off support regardless of the leak. There was no patient harm, and the patient was weaned off successfully. The patient was covid positive, so the hls disposable was disposed of. Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 12851484
• MDR Text Key: 281130394
• Report Number: 8010762-2021-00619
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• 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
• Report Date: 11/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BEQ-HLS 7050
• Device Catalogue Number: 701052794
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown