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 Insufficient Information (4580)

Event Date 05/07/2021

Event Type  Death  

Manufacturer Narrative

The affected oxygenator was requested for further investigation but not received yet.Therefore the investigation is pending.A follow up medwatch wil be submitted when new information becomes available.

Event Description

Reporting decision was changed due to new information was received on 2021-05-14: it was reported that both hls sets primed had issues with pven reading on the cardiohelp.The first hls set attempted the pven was jumping all around before priming and then once prime it stayed at a constant -500.The second hls set showed to be okay during priming but once on support it was reported that it stayed at a steady +600 reading.Complaint # (b)(4).

Manufacturer Narrative

It was reported that both hls sets primed had issues with pven reading on the cardiohelp.The first hls set attempted the pven was jumping all around before priming and then once prime it stayed at a constant -500.The second hls set showed to be okay during priming but once on support it was reported that it stayed at a steady +600 reading.The circuit used on the patient was discarded of.The patient expired.The two hls modules were investigated in the getinge laboratory on 2021-07-05.During the functional tests, the reported failure " pven reading on the cardiohelp" could not be confirmed on both returned hls sets.Both products displayed comparable values for venous pressure during the sensor test.No changes in pressure values were observed.In addition, no damage or other deviations were detected during the visual inspection of the complete sensor system.For further investigation a medical review was performed by getinge medical affairs on 2021-08-04 with following outcome: the possible root causes of the behavior observed by the customer may be any of the following: improper seating of the sensor cable to the hls set or to the cardiohelp system.This may be indicative of a use error.Misalignment of the sensor cable to the pin configuration of the hls set.This may be indicative of a use error.Faulty sensor cable.This was not tested by maquet.Incorrect zeroing of the transducers.This may be indicative of a use error.The transducers require zeroing while the hls circuit is free of liquids.With respect to the expiration of the patient, no data or details have been provided by the customer/user that addresses this outcome.It is unknown if the expiration of the patient is related to the product, a patient condition, or some other unfortunate, influencing factor.Under these conditions it cannot be attributed the expiration to anything in particular without further input and details from the customer/user.The production records of the affected hls modules were reviewed on 2021-08-12.Following tests are performed according to the bop as a 100 % inspection: gluing of sensors, gluing of cover for temperature and pressure sensor, functionality test hls module (sensors and pump).According to the final test results, the oxygenators with the serial# (b)(6) passed the test as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on these investigation results the reported failure could not be confirmed.The occurrence rate was calculated for the reported issue 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.

Event Description

Complaint id # (b)(4).

• 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: 11831686
• MDR Text Key: 250833408
• Report Number: 8010762-2021-00298
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70144812
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death