MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

It was reported that on morning of (b)(6) 2019 during system control, it was noticed that very bloody condensation water emerged from the gas outlet of the oxygenator (about 20 ml).Careful blowing of the oxygenator at 7l / min resulted in further bloody water.That's why the hls set was changed.The defective kit (lot 70132912, be-015703112) was then rinsed with tap water and ready for collection and further assessment by getinge.A patient's risk of the defect is extremely unlikely, since the change took place uncomplicated within a few minutes.Internal ref.No.(b)(4), onesupport: (b)(4).

Event Description

Internal ref.No.(b)(4), onesupport: (b)(4).

Manufacturer Narrative

Maquet gmbh requested the product in question for further investigation but the hls set was already disposed.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated was performed and the case tw#(b)(4) was found.Results of investigation: a leak test according to lv 201 was carried out and a leakage from the blood side to the gas side was detected.A most probable root cause could not be determined.Thus the failure could be confirmed.The occurrence rate is below the acceptance rate, thus no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9361653
• MDR Text Key: 200665350
• Report Number: 8010762-2019-00369
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1