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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During patient-use arterial pressure measurement and arterial temperature measurement start to jump up and down.Therefore the part, the delta-p and the arterial temperature could not be used during further therapy.After changing the hls set and rinsing with saline solution condensed water and some yellow solution was visible within the chamber of the sensors.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the arterial pressure (p-art) and temperature (t-art) was measured incorrectly.The hls module was investigated in the getinge laboratory on 2021-03-30.During a tightness test no leakage was noticed.The hls module was connected to a cardiohelp unit and the arterial temperature and pressure was measured over a time period of two hours.Both values were fluctuating.Upon visual inspection deposit (e.G.Due to priming fluid) at the sensors and a bent circuit board was detected.The production records of the affected hls module (dms# (b)(4)) were reviewed on 2021-04-01.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Based on the investigation results the reported failure "p-art and t-art reading incorrect" could be confirmed.The most probable root cause was determined as a bent circuit board leading to a damaged flexible conductor and thus a disconnecting of the arterial sensors.This was most probable caused by an assembly error in combination with external forces (e.G.Mechanical hit, humidity, fluids, temperature).The operators in the production were re trained on the bop concerning the assembling.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
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11300588
• MDR Text Key: 230955070
• Report Number: 8010762-2021-00103
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1