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

Model Number BE-H 100200

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that there is a kink on the 3/8 ¿ ¼ connection post-pump part of the tubing set.It was detected prior to use however, the product was used on a patient by placing in such a manner as to straighten out the kink.No harm or death to any person was reported.Complaint: (b)(4).

Event Description

Complaint # : (b)(4).

Manufacturer Narrative

It was reported that there is a kink on the 3/8 ¿ 1/4 connection post-pump part of the tubing set.It was detected prior to use however, the product was used on a patient by placing in such a manner as to straighten out the kink.The customer also reported an extra haemofilter line included in the pack, not packed in a separate package and just laid in the tray amongst the other tubing.No harm or death to any person was reported.- investigation of the kinked tube: the customer provided a photograph of the kink and extra line.It could be seen that the post pump line is kinked, looks like pressed.The picture shows inside the tray that the product is not placed appropriately and the products are moving inside the pack.The extra line is inside the tray lying with two connectors at the ends and one is blue the other is clear.The customer reported that that the tray is not placed appropriately and the products are moving inside the pack.The production history record (dhr) of the affected be-h 100200 with lot#3000152711 was reviewed.According to the dhr results, the product be-h 100200 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The relevant packaging controls were in place per the production history record review.Therefore, it could be concluded that the inlay to fasten the products in the tray might be gotten loose due to vibration and impact during transport.In addition to this getinge reseach & development (r&d) evaluated the packaging of the tubing set in a tray.And it could be concluded that the packaging could be contributed to the failure because the kinked part (post-pump line) is close to the tray wall.That could cause the product to be pressed and eventually kinked.The customer also suspected that the two sided bands to fasten the pump in the tray is not very sticky.There is no evidence found that the self-adhesive two-sided tape was not sticky.This tape is also used in other tubing sets than the one reported in this complaint.The trend search for ncs and complaints do not show issue in regards to the 750000300 self-adhesive two-sided tape for the last 24 months.The supplier of the band 3m also confirmed that there has not been any change with the band which affects the quality.The customer reported that he assumes when the circuits are sterilised (gassed) during manufacture that they are heated, at this point if the tubing is kinked the memory can stay in the tubing, only an assumption.This batch was sterilized within cycle 1373.The sterilization parameters were found compliance with the specifications.Based on this, the failure 'kink' could be confirmed.Based on the investigation results the most probable root causes of the kink are: - the packaging of the tubing set in a tray: this could be contributed to the failure because the kinked part (post-pump line) is close to the tray wall - the excessive or inadequate physical force: the inlay might be gotten loose due to excessive or inadequate physical force which could be occurred due to vibration and impact during transport/storage and eventually cause the kinked tube.- investigation of the extra line in the pack: the picture provided by the customer shows a line with with blue cap.This kind of cap is not used for ctps with mcp.Most probably the parts were thrown into the tray in the theatre and extra line is one of them.Based on this, the failure 'extra line' could not be confirmed.The occurrence rate was calculated for the reported failure and product 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: TUBING SET
• Type of Device: TUBING, PUMP, 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: 15724063
• MDR Text Key: 304348141
• Report Number: 8010762-2022-00433
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: BE-H 100200
• Device Catalogue Number: 701063919
• Device Lot Number: 3000152711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1