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

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

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

There was a tear in the packaging of the hls set when it arrived from shipping.There we no tears in the shipping material.Complaint id #(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that there was a tear in the packaging of the hls set when it arrived from shipping.There we no tears in the shipping material.Not used on patient.No harm was reported.The affected product was technically investigated at the laboratory of the manufacturer on 2022-03-22.During visual inspection a hole was detected within the tyvek cover of the hls intellipack.The sealing of the tyvek cover was still intact.After opening of the intellipack 1 it was detected that the velcrostraps (attached to the hls module) was fully detached because it slipped.Additionally, weld points of the welded inlay of the intellipack 1 were no longer intact.Thus the reported failure "tear in the packaging of the hls set " could be confirmed.The root causes of the reported failure "puncture in top of hls set packaging" were determined to be a detachment of inner and outer tray due to a weld failure resulting in dislodging of the hls module into the tyvek foil as well as a loose principle of packaging of parts which caused free space for movement during transport which damages the sterile tyvek cover and creating holes.Maquet cardiopulmonary has already triggered a corrective action within the capa process in order to improve the design to prevent such packaging damage in the future.The affected product was produced before the corrective action was implemented.The corrective action contains of implementation of adequate fixed inlay within tray and secure accessory items within the packaging of hls set.The production records of the affected hls set (batch #3000160186 ) were reviewed on 2022-03-24.Following steps are performed with a 100 % inspection: welding of inlay.Packaging.Final check.According to the final test results, the hls module with serial number (b)(6) passed the tests as per specifications.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: 12819225
• MDR Text Key: 280807526
• Report Number: 8010762-2021-00610
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000160186
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1