MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VKMO 70000 #QUADROX-I HMO 70000+VHK71; RESERVOIR

Model Number 70106.4523

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2014

Event Type  malfunction  

Event Description

It was reported that after priming, continuous air was in the venous line.The leakage was noted in the reservoir venous inlet port in the temperature probe.Leakage repair, checked again, ok.No reported patient effect.(b)(4).

Manufacturer Narrative

The device has not been returned for evaluation.Additional info: the product mentioned under section d is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510(k): k102919.A supplemental medwatch will be submitted if additional info becomes available.

• Brand Name: VKMO 70000 #QUADROX-I HMO 70000+VHK71
• Type of Device: RESERVOIR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4550627
• MDR Text Key: 5526750
• Report Number: 8010762-2015-00110
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: 70106.4523
• Device Catalogue Number: 70106.4523
• Device Lot Number: 92138699
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2014
• 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