MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer stated the pump had pint reading of 500 but they did not believe this to be accurate.In order to stop the alarm from going off they rezeroed the pressure.A few hours later the pven reading went to -700 and stopped the pump.They emergently swapped out cardiohelp machines and resumed patient support.However, after a few hours the issue returned and persisted leading them to believe it was possibly the hls set.Complaitn id:(b)(4).Note: the cardiohelp was reported under complaint id (b)(4), emdr#396408 (mfg report number.8010762-2020-00402).The issue was also reported to the fda under mw5098085.

Event Description

Complaint id: (b)(4) note: the involved cardiohelp unit was reported under emdr #396408 (8010762-2020-00402) and emdr follow up #397227.Further the issue was reported under mw5098085.

Manufacturer Narrative

The production records of the affected hls module were reviewed on 2020-12-23.According to the final test results during and after production, all oxygenators passed the test as per specifications.Production related influences can be excluded.A review for complaints with similar reported failures was performed and the complaints # 240775 and # 282763 were found.As stated in the corresponding investigations following most probable root causes could be determined: -internal sensors got wet and therefore measured faulty pressures -pressure connector corroded (e.G.Due to priming fluid) based on this the failure could be confirmed.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is 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: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10974839
• MDR Text Key: 220741357
• Report Number: 8010762-2020-00428
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• 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: 12/23/2020

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 Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1