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 there were two small cuts in the sterile packaging when the hls kit arrived by the customer.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that there were two small holes in the sterile packaging (tyvekcover) when the hls kit arrived by th customer.The set was not used for treatment.No harm to any person has been reported.The affected beq-hls 7050 usa#hls set advanced 7.0 with lot#3000180318 was investigated in the getinge laboratory.During the investigation two holes with a diameter of 9,3 mm and 5,1 mm could be confirmed.Additionally two dents within the carton on top of the tyvek with a diameter of 1,1 mm and 7,5 mm were found.The sealing of the tyvek cover was still intact.After opening the intellipack 1 it was detected that one of the 2 velstraps was not fully tightened.The other one was loose.The welding points of the welded inlay of the intellipack 1 were intact.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.This can 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 on the investigation results the reported failure "holes in sterile packaging" could be confirmed.Root cause analysis/further actions are ongoing.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

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.This can 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.As a preventive action mcp production was informed about the investigation results in a previous complaint and a retraining of the affected process was performed.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: 12768825
• MDR Text Key: 280452553
• Report Number: 8010762-2021-00591
• 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,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000180318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1