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

Model Number BO-VKMO 71000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a leak was detected at dial-lock connector (dialysis lock with valve) of oxygenator.The failure was detected during priming.However, customer mounted an dial lock adapter at the leak point and used the product for treatment.No leakage was occurred during treatment.No harm or death to any person was reported.Complaint #(b)(4).

• Brand Name: OXYGENATOR
• 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: 18985795
• MDR Text Key: 338693404
• Report Number: 8010762-2024-00167
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-VKMO 71000
• Device Catalogue Number: 701067951
• Device Lot Number: 3000326764
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Date Device Manufactured: 07/06/2023
• 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