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

Model Number BEQ-HLS 7050 USA

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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 upon opening box containing hls set a small hole was noticed in the inner peel back top of the hls set.A new hls set was opened and used.Complaint id: (b)(4).

Manufacturer Narrative

The cause of the reported failure "small hole in inner peel pack" was determined to be loose velcrostraps causing enough freedom of movement of the hls module to made it possible to pierce through the tyvek cover of the hls intellipack during transport.The velcrostraps were crossed over the dia-connector of the oxygenator module during packaging of the product which made it possible for them to slip from this location during transport.Preventively mcp r&d packaging was informed about the investigation results.An ecr (engineering change request) was started in order to adapt the work instruction and describe that the velcrostraps should not be crossed over the dia-connector anymore.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).

Manufacturer Narrative

The event occurred in the us.The following complaint information was provided to maquet cardiopulmonary: "upon opening box containing hls set a small hole was noticed in the inner peel back top of the hls set.A new hls set was opened and used." no harm to any person has been reported.The affected product was investigated in the getinge laboratory.Hereby a hole within the tyvek cover of the hls intellipack of a diameter of 8,0mm was confirmed.Additionally a dent was detected within the protective carton over the intellipack.No other damages were detected.After opening the intellipack it was detected that the velcrostraps needed for fixating the hls module within the inlay were a bit loose.It was determined that the velcrostraps were not crossed over the diaconnector of the hls module anymore as foreseen by a picture within the appropriate packaging process.The most probable cause of the reported failure "small hole in inner peel pack" was determined to be loose velcrostraps causing enough freedom of movement of the hls module to made it possible to pierce through the tyvek cover of the hls intellipack.Based on the investigation results the reported failure "small hole in inner peel pack" could be confirmed.Root cause analysis/further actions are ongoing.

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: 12932531
• MDR Text Key: 281734092
• Report Number: 8010762-2021-00640
• 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
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701069078
• Device Lot Number: 3000193359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1