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 Packaging Problem (3007)

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

Event Date 08/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.A field safety corrective action (fsca#656504) has been implemented on july 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

The event occurred in france.It was reported that a visible hole in the tyvek of the sterile packaging of an hls set was noted.The affected hls set with lot#3000224137 is part of the fsca#656504.No patient was involved.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a visible hole in the tyvek of the sterile packaging of an hls set was noted.No patient was involved.No harm to any person has been reported.The affected product was technical investigated in the getinge laboratory on 2022-10-13.The packaging condition of the complaint product conforms to the specification and the production specifications.The extent and shape of the damage indicate that the tyvek may have been subjected to an external force.As part of this report preparation, information was obtained from the designated complaint unit, that the customer stores the hls set advanced products in the corresponding area without outer packaging.Due to the characteristic shape and form of the damage, as well as the additional information about the storage, it is possible to expand the possible cause of the damage can be made.For example, if the tyvek is stored on a shelf, it may come into contact with a sharp-edged with a sharp-edged object and thus to the drawing marks and the damage.A possible root cause could be an external force applied to the tyvek by a separate object not associated with the product or its packaging.The affected be-hls 7050 #shls set advanced 7.0 with lot#3000224137 has been reviewed for the reported failure on 2022-10-14.According to the final test results, the hls sets with the lot# 3000224137 passed the tests as per specifications.Based on the investigation results, the reported failure "hole in tyvek" could be confirmed, but was related to an external force caused by a separate object not associated with the product or its packaging.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: 15326271
• MDR Text Key: 301341815
• Report Number: 8010762-2022-00352
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000224137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1