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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Pumping Stopped (1503)

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

Event Type  malfunction  

Event Description

It was reported that the pump of the cardiohelp stopped during treatment due to disposable error.The emergency drive was used till the cardiohelp was exchanged.No harm to patient has been reported.Complaint id #(b)(4).

Manufacturer Narrative

The investigation is ongoing.A follow-up emdr will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

The affected hls module was investigated in the getinge laboratory on 2022-05-31.The visual inspection does not show any damages on the hls module.Blood clots can be confirmed in the centrifugal pump of the hls module.These clots can lead to noise and impairment of the flow rate, depending on the spread and position of the blood clot and a stop of the centrifugal pump is unlikely.Further investigation shows that the position of the magnets was correct.The module could be primed without any abnormalities with regard to the centrifugal pump.The function test shows no abnormalities.Coupling and decoupling the module several times in the cardiohelp does not lead to any changes.Thus the reported failure could not be reproduced.A follow-up emdr will be submitted when additional information becomes available.

Manufacturer Narrative

Further investigation steps are performed on 2022-07-26 in the getinge laboratory with the following results: the additional information were provided in the investigation of the cardiohelp involved in the event (mcp ref.600744).A getinge service technician (fst) was sent for investigation on 2022-03-10 and recognized that the pump disposable error was found to be due to a misdetection of the hls set.According to the cardiohelp risk file following root causes can lead to the reported failure: occlusion in the disposable, no or insufficient coupling between the cardiohelp and the hls set, magnetic coupling disturbed.Based on these investigation results the reported failure could be confirmed, but the exact root cause could not be determined, since the investigated hls module was fully functional.The production records of the affected hls module were reviewed on 2022-06-24.Following tests are performed according to the bop as a 100 % inspection: pressure test heat exchanger, leak test water/gas side, pressure test blood side, final functional test.According to the final test results, the hls module with lot number 3000182956 and serial number (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The customer will be informed about the results by the getinge sales and service unit.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
• 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: 13856303
• MDR Text Key: 287662754
• Report Number: 8010762-2022-00097
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073 (HLS SET)
• Device Lot Number: 3000182956 (HLS MODULE)
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose