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

Model Number BEQ-HLS 7050 USA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The affected product was not available for technical investigation of the manufacturer as it was disposed off.The exact root cause could not be determined.However, the reported failure "blood leaking from gas outlet port" was investigated in a previous complaint with the following results: during a tightness test of the hls module water was leaking out of the gas outlet port.The most probable cause of the reported leakage could be: inadequate pur potting, fiber delamination, fiber damage.Hereby blood can leak either to the outer cover plate, or between fibers and pur potting or through the oxygenating fibers self.The leaking blood collects at the lowest port of the oxygenator (gas outlet port) and therefore leads to the reported failure.Based on the above mentioned investigation results and on the picture the customer provided the reported failure "blood leaking from gas outlet port" could be confirmed.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 blood leaked from the gas outlet port of the hls module.Circuit was setup and primed the same day.Patient had been on the circuit for 6 hours before the leak was noticed upon sighing.It was left for another 6 hours before circuit was changed out.Minimal blood loss and no effect to the patient except the procedure for circuit changeout.Set was disposed of therefore unfortunately not available for return and investigation.No harm to any person was reported.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: 13050997
• MDR Text Key: 282546795
• Report Number: 8010762-2021-00667
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701069078
• Device Lot Number: 3000193358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose