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

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

Device Problem Packaging Problem (3007)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported that the affected hls set has a corner open as known from fsca-661861.The failure occurred out of package.No harm to any person has been reported.Complaint id#(b)(4).

Manufacturer Narrative

Further investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.A field safety corrective action (fsca#661861) has been implemented on (b)(6) 2022.The hls set advanced is intended for use in an extracorporeal circulation for cardiac support and/ or pulmonary support.Maquet cardiopulmonary gmbh (mcp) has received customer complaints of damage to the primary packaging of the hls set advanced.In all customer complaints it was reported that the tyvek cover was damaged.The appearance of the packaging failure can be hole(s) in the tyvek.The damages are caused by the tabs of the venous probe holder within the packaging.To improve the detectability of the damage actions have been implemented which includes the return of the products and a customer on-site device inspection.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the affected hls set has a corner open on the tyvek cover.The failure occurred during unpacking of the hls set.The defect was noted prior to use and no patient was involved.No harm to any person has been reported.The affected hls set was investigated in the getinge laboratory on 2023-01-18 with following conclusion: during visual inspection two open areas of the tyvekcover could be confirmed.In addition, several brownish stains, some of which were extensive were visible on the tyvek cover.Further investigation steps showed that the seal was fully present on the intellipack tray.On the affected corners of the tyvek cover, the typical signs of kinking from manually opening the set could be seen.At the sealed areas, the tyvek cover was tightly bonded to the intellipack tray.The sealed seam was straight and continuous up to the open areas.No defects such as gaps, channels or transparent areas could be observed in the entire area of the sealed seam.No abnormalities could be detected in the present sealing, which would indicate a faulty sealing of the intellipack tray.A most possible root cause for the open area could not be determined during the investigation.The affected production records have been reviewed for the reported failure on 2023-01-30.According to the final test results, the hls set passed the tests as per specifications.Based on the results the reported failure "open corner on the tyvekcover" could be confirmed, but the exact root cause could not be determined.The customer will be informed about the results by the getinge sales and service unit.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.

• 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: 15318051
• MDR Text Key: 305494023
• Report Number: 8010762-2022-00349
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000228866
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1