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  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the customer claims that 1 of the hls set was damaged when they received it.It had 2 holes in the top of the packaging.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the customer claims that one of the hls set was damaged when they received it.It had 2 holes in the top of the packaging (tyvekcover).The set was not used for a patient.No harm to any person has been reported.The affected beq-hls 7050 usa #hls set advanced 7.0 with lot #3000165560 was investigated in the getinge laboratory.During the investigation four holes with a diameter of 16, 6 mm, 5, 9 mm, 7, 8 mm and 12, 6 mm could be confirmed.The sealing of the tyvek cover was still intact.After opening of the intellipack 1 it was detected that the velcostraps (attached to the hls module) were not fully tightened.Additionally, two weld points of six at the welded inlay of the intellipack 1 were no longer intact.The root causes of the reported failure "damaged packaging hls set/holes in tyvekcover" were determined to be a combination of a detachment of inner and outer tray due to a weld failure resulting in dislodging of the hls module into the tyvek foil and an individual cause which was determined to be an inadequate fasteing of the hls module onto the insert of the intellipack 1.This led to vertical movement of the hls module during transport whereby the brackets of the venous measurement cell at the blood inlet connector pierced the sterile tyvek cover of the intellipack 1.Based in the investigation results the reported failure "damaged packaging hls set/holes in tyvekcover" could be confirmed.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 beq-hls 7050 usa#hls set advanced 7.0 with lot #3000165560 were reviewed on 2022-04-22.According to the final test results, all beq-hls 7050 usa#hls set advanced 7.0 sets with lot #3000165560 passed the tests as per specifications.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.

• 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: 12581801
• MDR Text Key: 274905101
• Report Number: 8010762-2021-00543
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000165560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1