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

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

Device Problems Unable to Obtain Readings (1516); Device Sensing Problem (2917)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

The event occurred in the usa.It was reported that during patient treatment, they were unable to get a consistent pressure reading from the pressure/temperature cable.They replaced the cable two times without any change.They continued the treatment of the patient and did not exchanged the hls set.The patient was supported as anticipated.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Manufacturer Narrative

The affected hls-set was investigated by the getinge laboratory on 2023-03-08 with following conclusion:  there were no obvious damages found on the product during the visual inspection.The arterial pressure was not displayed.Inside the housing of the arterial sensors, corrosion in the area of the blood outlet connector was found.The failure "arterial pressure was not consistent reading" which was reported by the customer could be confirmed. this type of corrosion occurs when an electrolyte such as saline solution or priming fluid, in general, is involved.If an electrical voltage is applied, the process of corrosion is accelerated.The corrosion and the resulting damage and deposits can impair the electronics and lead to the total failure of the electronic components.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during patient treatment, they were unable to get a consistent pressure reading from the pressure/temperature cable.They replaced the cable two times without any change.They continued the treatment of the patient and did not exchanged the hls set.The patient was supported as anticipated.No harm to any person has been reported.The affected hls-set was investigated by the getinge laboratory on 2023-03-08 with following conclusion: there were no obvious damages found on the product during the visual inspection.The arterial pressure was not displayed.Inside the housing of the arterial sensors, corrosion in the area of the blood outlet connector was found.The failure "arterial pressure was not consistent reading" which was reported by the customer could be confirmed. this type of corrosion occurs when an electrolyte such as saline solution or priming fluid, in general, is involved.If an electrical voltage is applied, the process of corrosion is accelerated.The corrosion and the resulting damage and deposits can impair the electronics and lead to the total failure of the electronic components.An additional test was made on 2023-03-30 in the getinge laboratory.During the test for leak tightness of the sensor area in the blood outlet connector, no deviations could be detected.This rules out any leakage from the blood side into the sensor housing is excluded.The penetration of electrolyte described above must therefore have occurred from the outside.Based on the results the reported failure "pressure reading not consistent" could be confirmed.The exact root cause could not be determined.The production records of the affected be-hls 7050 #shls set advanced 7.0 with packaging lot# 3000242457 and basic lot# 3000233069 were reviewed on 2023-04-17.According to the final test results, the hls module with lot# 3000242457 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely.The customer will be informed about the results by the getinge sales and service unit.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
• 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: 16120236
• MDR Text Key: 308162551
• Report Number: 8010762-2023-00008
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000256687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose