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

Model Number HLS SET ADVANCED

Device Problems Material Puncture/Hole (1504); Packaging Problem (3007)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that the hls tubing set container sealant cover has a hole puncture.There was no damage or puncture on the outer package cart box reported.The cart box was discarded by the customer.No patient was involved.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the hls tubing set container sealant cover has a hole puncture.There was no damage or puncture on the external cart box.The cart box was discarded.The affected hls set packaging was investigated by the getinge laboratory on 2023-06-22 with following conclusion: during visual inspection the reported failure hole in tyvek could be confirmed.The hole in the tyvek was most probably caused at customer site due to external force.Moreover, in the instruction of use (ifu) of the hls set in chapter 4.1 basic safety instructions it is stated to not use the device if it or the sterile packaging is damaged and to not stack sets on top of each other in their primary packaging, as this can result in a damage of the sterile packaging.The production records of the affected product hls set has been reviewed for the reported failure on 2023-06-22.According to the final test results, the hls set passed the tests as per specifications.Based on the results the reported failure "hole in tyvek" could be confirmed, but was not product related.The customer will be informed about the results by the getinge sales and service unit.

• Brand Name: TUBING SET
• 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: 17000824
• MDR Text Key: 315912109
• Report Number: 8010762-2023-00231
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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 Expiration Date: 06/14/2023
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: 701069073
• Device Lot Number: 3000248908
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1