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

Model Number BO-HQV 141500-J#VKMO 31000

Device Problem Leak/Splash (1354)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a leakage was detected at the sampling line of vkmo 31000 during priming.Customer changed the tube at the sampling line and used the product for treatment.Treatment was completed without any problem however due to a poor welding between connector and tube, the operation was hard.No harm to any person was reported.Complaint (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

It was reported that a leakage was detected at the sampling line of vkmo 31000 during priming.Customer changed the tube at the sampling line and used the product for treatment.Treatment was completed without any problem however due to a poor welding between connector and tube, the operation was hard.No harm to any person was reported.Sample investigation could not be performed since the product was discarded by customer.Further, dhr review could not be performed since the affected product lot number was not provided.Customer complaint trend search was performed for 4 years and for this specific line.There could not be found any similar complaint record.Review of the non-conformities was performed and there could not be found any non-conformity record that could cause to reported failure for this specific product.Based on the investigation results, this complaint could not be confirmed.Exact root cause could not be determined.However, the reported failure could be linked to the risk assessment and control of tubing sets and the causes could be related with: stationery and transport conditions: mechanical damage of product during transportation due to vibration and impact.Manufacturing: cut or scratch on inside/outside of device compromising component.Lack of attention on device handling, mechanical damage of the tubing set.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.

• 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: 18463246
• MDR Text Key: 332262143
• Report Number: 8010762-2024-00013
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/26/2024

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 141500-J#VKMO 31000
• Device Catalogue Number: 701076229
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose