MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in the us.It was reported that a patient had been on cardiohelp for 24 days on same hls set.Perfusion notice brown water in the heater cooler line.They changed out the heater cooler unit and noticed the same problem.The used cardioquip heater cooler is manufactured by cardioquip.The hls set was then changed out with no adverse effect to the patient, and the issue went away.Brown water was noted almost immediately after the second heater cooler was used.The customer indicated, that there were no other issues with the hls set.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that a patient had been on cardiohelp for 24 days on same hls set.Perfusion notice brown water in the heater cooler line.They changed out the heater cooler unit and noticed the same problem.The used cardioquip heater cooler is manufactured by cardioquip.The hls set was then changed out with no adverse effect to the patient, and the issue went away.Brown water was noted almost immediately after the second heater cooler was used.The customer indicated, that there were no other issues with the hls set.No harm to any person has been reported.The affected beq-hls 7050 usa #shls set advanced 7.0 was investigated in the getinge laboratory on 2022-09-08 with the following results: a tightness test of the water, gas and blood side was performed and the reported failure could be confirmed.During the investigation a leakage on the waterside was detected which could lead to the reported failure.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 based on the investigation results the reported failure "brown water in the heater cooler lines" could be confirmed.Maquet cardiopulmonary initiated a non-conformance process in order to investigate this issue further and to implement corrective and preventive actions.All further actions and investigations will be performed within this process.The production records of the affected beq-015503112#hls mod advanced small ad.With lot#3000205803 were reviewed on 2022-08-31.According to the final test results, the beq-015503112#hls mod advanced small ad.With lot#3000208803 and serial number 1826137 passed the tests as per specifications.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• 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: 15091418
• MDR Text Key: 302074137
• Report Number: 8010762-2022-00283
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000221755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1