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 Fracture (1260)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the small fixed part at the blood inlet connector of the hls set, which is used to connect and fix the venous probe, was broken.Therefore, the venous parameter could not be monitored.The hls set was exchanged during patient treatment.No harm to any person has been reported.The affected product was requested for further investigation but it was not possible to export the product out from china due to custom regulations.Therefore a technical investigation could not be performed at the getinge laboratory.Thus, the exact root cause could not be determined.In addition, pictures were provided by the customer on which the broken blood inlet connector is clearly visible.However, the reported failure "broken venous probe cell connector" can be linked to the following most possible root causes according to our risk management file (hls set, dms # 1468452, v26): - holder of venous probe breaks, - mechanical damage to the venous probe cell connector.The device history review records were reviewed on 2022-08-23 for the reported failure.According to the final test results, all hls module with packaging lot # 3000194193, 3000194192 and 3000195945 passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results and the provided pictures by the customer the reported failure "broken blood inlet connector" could be confirmed.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use - hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 | g-360 | version 03 | nonus chapter: 7.1 preparation and installation damage to the device or packaging.A non-sterile or defective device can result in patient infections.Perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.Instructions for use / heart-lung support system / cardiohelp system | 1.10 | nonus | 11 chapter: 5 preparing application, 5.2.3 attaching the venous probe to the measuring cell - in order to prevent the retaining hook breaking off at the set breaking point, attach the venous probe to the measuring cell carefully.Press the probe carefully onto the disposable's measuring cell until the retaining hook clicks into place in the probe.Ensure that the probe is correctly positioned and securely fixed.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

The event occurred in china during patient treatment.It was reported that the small fixed part at the blood inlet connector of the hls set, which is used to connect and fix the venous probe, was broken.Therefore, the venous parameter could not be monitored.The hls set was exchanged during patient treatment.No harm to any person has been 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: 15310287
• MDR Text Key: 298798179
• Report Number: 8010762-2022-00346
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112360
• 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
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000205877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1