MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BO-HQV 70600#ADULT PACK; RESERVOIR

Model Number BO-HQV 70600

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that the temperature probe at the venous inlet was not tight.Air was constantly being sucked into the venous reservoir.The temperature probe was removed and replaced with a plug from the reservoir.This did not solve the problem.Think it may be female luer lock in which the probe is inserted and not the temperature probe.No reported pt effect.(b)(4).

Manufacturer Narrative

The device has not been returned for eval.A follow up medwatch will be sent when add'l info is received.Add'l info: the product mentioned, is a tubing set with reservoir and the included affected component has the contributing design function of th reservoir which is registered under 510 (k): k102919.

• Brand Name: BO-HQV 70600#ADULT PACK
• 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: 4536042
• MDR Text Key: 17634782
• Report Number: 8010762-2015-00097
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: BO-HQV 70600
• Device Catalogue Number: 70104.5308
• Device Lot Number: 92119899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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