MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING

Model Number BEQ-HLS 7050

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

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that an oxygenator was noted to be leaking during set-up.The filament (pigtail/extension stopcock) was changed, but the leak continued.The next morning the circuit was checked, the device was still leaking, so it was changed out.It was reported the device was cracked at the arterial port and leaked approx 30 cc.No pt involvement.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary is aware of similar complaints.Similar products showing a similar malfunction have been investigated.Leakage at the luerlock of the blood inlet was confirmed in the laboratory.Review of the quality control process indicates that 100% functional inspection for leakage is performed during mfg.This should be adequate to detect products that do not meet the performance specs prior to release for final packaging and sterilization.This data is also being handles through a designated maquet cardiopulmonary tracking and trending process.No further investigation will be performed at this time.A supplemental medwatch will be submitted if add'l info becomes available.Add'l info: 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/BIOLINE COATING
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4379688
• MDR Text Key: 5288685
• Report Number: 8010762-2014-01387
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050
• Device Catalogue Number: 70105.2794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1