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

Model Number BEQ-HLS-7050

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that when (b)(6) (group purchasing organization partner) opened up the master carton to item 701052794 he noticed the protective sheet (sterile hls set tray cover) was pierced.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that when the warehouse of hospital corporation of america (group purchasing organization partner) opened up the master carton to item 701052794 he noticed the protective sheet (sterile hls set tray cover) was pierced.No harm to any person was reported.The product was not used for patient treatment.The affected product was technically investigated at the laboratory of the manufacturer.Hereby a hole with a diameter of approx.7,8mm was detected within the tyvek cover of the hls intellipack 1.The sealing of the tyvek cover was still intact.After opening of the intellipack 1 it was detected that 2 of the 2 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 most probable cause of the reported failure "protective sheet was pierced" was 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 "protective sheet was pierced" could be confirmed.The root cause analysis / further actions of the manufacturer are still ongoing.

Manufacturer Narrative

The root causes of the reported failure "protective sheet was pierced" 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.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.As a preventive action for the individual cause (inadequate fasteing of the hls module) maquet cardiopulmonary has informed production and a retraining of the affected process was performed.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: 12574661
• MDR Text Key: 274693547
• Report Number: 8010762-2021-00541
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

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
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70144811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 01/26/2022
• Supplement Dates FDA Received: 01/13/2022; 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1