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 Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Hls set was discarded by customer.

Event Description

It was reported that on (b)(6) 2023 a patient arrived which needed a treatment with the ecmo.During opening the circuit of the hls set the latter proved to be defective at the level of the electronic connectors.The priming was carried out without any problem, then there was a fault in the electronic line with a green appearance which is inserted into the pump body.It was impossible to zero the arterial pressure and there was no delta pressure displayed.Therefore the monitoring remained impossible as the saturation monitoring also failed very quickly.The black pressure cable was changed without any success.The affected hls set was discarded.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that on (b)(6) 2023 a patient arrived who required a treatment via the cardiohelp and the hls set.During the opening of the circuit the latter proved to be defective at the level of the electronic connectors.The priming was carried out without any problems.There was a fault with the green electronic line on the hls set.Therefore the arterial pressure could not be zeroed and there was no delta pressure, as well as the monitoring was impossible.Furthermore there was no svo2 (saturation) reading possible and the customer continued without this data.The hls cable was replaced, but did not solved the issue.There was no visible corrosion or defect on both hls cables.The hls set was discarded by the customer.Further the customer confirmed that there was no damage to the packaging and the priming procedure was very urgent.During unpacking the device no failure was detected.The customer further informed that when connecting the hls cable to the electronic connector of the hls set the cable was dangling and the glue of the green electronic flat cable was not well stuck to the hls set body.He informed that according to the absolute emergency situation and not impacting the operation of the pump and priming, the decision was made to continue the procedure, therefore the immediate realization of the ¿zero pressure¿ issue was impossible.The saturation failure will be investigated in another complaint id# 763047 (mfg report number#8010762-2023-00069) for the cardiohelp device.As the hls set was discarded an investigation of the device is not possible.However, according to the risk file of the hls set advanced, hit set advanced the following root causes can lead to the reported failure: - wrong pressure measurement due to a malfunction of the pressure sensor moreover, in the instructions for use of the hls set advanced 5.0/7.0 hit set advanced 5.0/7.0 it is stated in chapter 6.1 preparation and installation to carry out the calibration for each pressure parameter of the integrated sensors.To do this, the system must be free of liquids.For this reason, carry out the calibration before priming the set.The production records of the affected be-015703112 #shls module advanced adult passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "flat green cable of sensors defective" could not be established, as the product was discarded and no investigation is possible.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2022-01-23 till 2023-01-23).The customer will be informed about the results by the getinge sales and service unit.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.H3 other text : device was discarded by the customer.

Event Description

Complaint id# (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16276812
• MDR Text Key: 308720865
• Report Number: 8010762-2023-00061
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1