MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING; DTZ OR DWE

Model Number VKMO 31000

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Reintubate (2392)

Event Date 04/30/2015

Event Type  Injury  

Event Description

Description from the customer report: during priming customer noticed that the luer lock of the oxygenator on the outlet side was leaking.Perfusionist has replaced the oxygenator with a new one.No consequence to the patient, as the product was replaced before initiation of cpb.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary is aware of a similar complaints showing a similar malfunction.This failure has been previously investigated and fractures at the blood outlet connector have been identified.The review of the quality control process indicated that a 100 percent functional inspection for leakage is conducted during manufacturing.This should be adequate to detect products that do not meet the performance specifications prior to release for final packaging and sterilization.The test is carried out at 1 bar (approx 14 psi) for a time period of 75 min at a flow of 10 1/min.During this time each oxygenator is checked for any leakages.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510 (k): k101153.

• Brand Name: HLM TUBING SET W/SOFTLINE COATING
• Type of Device: DTZ OR DWE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4814419
• MDR Text Key: 5834890
• Report Number: 8010762-2015-00689
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 31000
• Device Catalogue Number: 70104.9185
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 75