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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

Cardiohelp disposable hls 7.0 generated noise that sounded like air.Venous probe attached did not trigger.Opening venous probe triggered alarm.Pullback from inlet pigtail did not yield any air.No change in any pressures or flow with sound.Hcp decided to change circuit and cardiohelp hardware.Circuit was rinsed and saved.Customer requests service call to inspect hardware.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

A device history review was performed on 2019-11-13 and no references found, which are indicating a nonconformance of the product in question.An investigation in the laboratory of the manufacturer was performed on 2019-12-06.The hls set was connected to a cardiohelp and ran with different rmp (rounds per minute).No noises or abnormalities were detected.The reported failure could not be reproduced.No root cause could be detected as there was no malfunction thus the failure could not be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.

• 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: 9334642
• MDR Text Key: 200416138
• Report Number: 8010762-2019-00365
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70127639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 11/10/2019
• Supplement Dates FDA Received: 12/06/2019
• Patient Sequence Number: 1