MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO-HQV 29201

Device Problem Material Deformation (2976)

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

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that when the set is opened, one of the tube that reached to the oxygenator was kinked.Customer tried to change the tube shape however it did not return the correct shape.However, customer used the product for treatment by changing the kink tube.No harm to any person has been reported.The product was discarded by customer however 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 29201 with lot# 3000314231 was reviewed on 2023-11-06.According to the dhr results, the product bo-hqv 29201 passed the defined manufacturing and final release specifications.The packaging configuration of the reported set has been controlled and it was found that the kinked tube is connected to the component 'quart' and this component is not fixated inside the package.Based on this, the movements of the quart component during transportation could cause to a tension at the tube and movements of the tube to the opposite site could cause to kink.Based on the investigation results within the complaint, the probable root cause has been found as: transport: the kink could be occurred during transportation due to the vibration and impact.Design: a packaging configuration failure has been detected.The components inside the package is not fixated, therefore movements during transportation / storage could cause kink.The detailed root cause analysis will be performed within capa #938922.Capa has been initiated for the reported failure ¿kink at tube¿ and for the reported product #701076679, be-mecc 142000.The reported product #701071045, bo-hqv 29201#circuito cec adulto within the complaint has been also included to scope of this capa.The further actions to determine corrective measures for the failure will be performed within the capa.All further steps will be performed in accordance to capa.Tubing set # 701071045, bo-hqv 29201#circuito cec adulto has been blocked in sap system on 2023-11-13 which is after the reported failure detected.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.

Event Description

It was reported that when the set is opened, one of the tube that reached to the oxygenator was kinked.Customer tried to change the tube shape however it did not return the correct shape.However, on 2023-12-15, a new information is received from getinge representative which states that the product was used for treatment by customer by changing the kinked tube with another tube.No harm to any person has been reported.Complaint (b)(4).

• Brand Name: TUBING SETS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 18381628
• MDR Text Key: 331379304
• Report Number: 8010762-2023-00641
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090533
• 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
• Report Date: 12/22/2023

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 Model Number: BO-HQV 29201
• Device Catalogue Number: 701071045
• Device Lot Number: 3000314231
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other