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 Date 11/17/2021

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 customer received 2 hls sets and one was crushed with the peel pack having a hole in it.No more information has been provided.No harm 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 customer received 2 hls sets and one was crushed with the peel pack (tyvekcover) having a hole in it.No harm to any person has been reported.The affected beq-hls 7050 usa#hls set advanced 7.0 was requested for investigation.But the requested product was scrapped therefore, a technical investigation could not be performed at the getinge laboratory.A review of the complaint data for similar complaints was performed and the reported failure was already investigated in a similar complaint and the most probable cause for the reported failure could be determined to be an inadequate fastening of the hls module onto the insert of the intellipack 1 as well as an isolated detachment of the insert from 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.Thus the reported failure "damaged packaging hls set/holes in tyvekcover" could be confirmed.The most probable cause of the reported failure "hole in sterile hls set cover" was determined to be an inadequate fasteing of the hls module onto the insert of the intellipack 1 as well as an isolated detachment of the insert from 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.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.To perform a device history review (dhr) is not possible as the lot number of the affected hls set is not available.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.H3 other text : 4115.

• 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: 12873805
• MDR Text Key: 281266606
• Report Number: 8010762-2021-00627
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/25/2021
• Supplement Dates Manufacturer Received: 05/03/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1