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

Model Number BO-HQV 89109

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.H3 other text : 4115.

Event Description

It was reported that after opening the tyvek (plastic peel), the user detected that the sterile bag which includes arterial and venous lines had been drilled.Further, the ends of this sterile bags are open and this sterile bag is packed in tray, sealed with tyvek with additional components in the tray.The whole set is sealed with tyvek cover.No harm to any person was reported.Complaint #: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that after opening the tyvek (plastic peel), the user detected that the sterile bag which includes arterial and venous lines had been drilled.Further, the ends of this sterile bags are open and this sterile bag is packed in tray, sealed with tyvek with additional components in the tray.The whole set is sealed with tyvek cover.No harm to any person has been reported.Sample investigation could not be performed since the product was discarded by customer.A photograph was received which shows the reported failure clearly.Based on this, failure could be confirmed.The production history records (dhrs) of the affected bo-hqv 89109 with lot# 3000312381 was reviewed on 2022-09-07.According to the dhr results, the product bo-hqv 89109 passed the defined manufacturing and final release specifications.Further, the incoming inspection reports of the affected component sterile bag / 04187#steriltüte 320 x 500 mm, #700004187 (batch # 3000258343) was reviewed on 2023-09-19.The sterile bag was checked visually for particles, puncture, pinhole, gap, tear, burn/meltdown, wrinkle, stain and smooth surface.All tests were passed as per specifications.It was found that the reported failure was occurred after the component change of sterile bag from #700009558, 09558#sterilbeutel to #700004187, 04187#steriltüte 320 x 500 mm.Further, the failure has been shared with packaging & process engineer.It was stated that the sterile bag #700004187, 04187#steriltüte 320 x 500 mm is not suitable as #700009558, 09558#sterilbeutel regarding the packaging configuration of this specific tube set.According to the received information from packaging & process engineer, the reasons of the hole at sterile bag are defined as follows: 1.The location of the sterile bag inside the tray includes another components under it which could cause damages on the paper side.2.Besides, #700004187, 04187#steriltüte 320 x 500 mm that contains medical paper is not suitable with this specific tube set packaging configuration.The paper side of the material #700009558, 09558#sterilbeutel is a tyvek and it was more appropriate for this configuration.Based on the investigation results, the most probable root cause has been found as: design failure: the medical paper sterile bag is not appropriate for the packaging configuration of the related tube set.Man failure: due to the lack of attention, the compliance of the change of tyvek to medical paper was not evaluated.Capa request has been initiated for the reported failure ¿hole at sterile bag¿ and for the reported product ¿701074464, bo-hqv 89109¿.Further actions will be handled in accordance with capa request.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 SETS
• 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: 17630097
• MDR Text Key: 322032119
• Report Number: 8010762-2023-00426
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-HQV 89109
• Device Catalogue Number: 701074464
• Device Lot Number: 3000312381
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other