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 Pumping Stopped (1503)

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

I received a call through the emergency tech support from (b)(6), perfusionist.They had an incident when a patient was on cardiohelp.It happened shortly after they moved the patient.Brian reported that the cardiohelp just stopped pumping, they couldn't flow, it was alarming like crazy, and it sounded like a ball bearing broke." he immediately primed a new hls set on a backup cardiohelp machine and put the patient on the new set.Brian could not recall what the specific alarms were, and the machine had since been turned off so the last 6 alarm situation recall didn't work.They were not recording data either.He had notified their biomed who are opening a service order, they would like service to determine the problem asap and also possibly need a rental.I told them to save the hls disposable by any means possible.Hls module lot#70130884, cardiohelp i sn (b)(4), udi #(b)(4).Complaint id: (b)(4).

Manufacturer Narrative

A device history review was performed on 2019-11-12 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 2019-12-05.During optical investigation damages on the pump housing were discovered.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.Thus no root cause could be determined and the failure could not be confirmed as no malfunction was detected.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.

Event Description

(b)(4).

• 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: 9305759
• MDR Text Key: 192163879
• Report Number: 8010762-2019-00358
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70130884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Date Manufacturer Received: 10/28/2019
• Patient Sequence Number: 1