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 Problem Device Sensing Problem (2917)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

The event occurred in the usa.It was reported that during patient treatment, a tart sensor alarm occurred with no readings.The arterial pressures were also displayed negative.The alarm continued even after the black sensor cable was troubleshot.There were no flow issues and the patient currently remains on the hls circuit.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

It was reported that during patient treatment, a tart sensor alarm occurred with no readings.The arterial pressures were also displayed negative.The alarm continued even after the black sensor cable was troubleshot.There were no flow issues and the patient currently remains on the hls circuit.No harm to any person has been reported.The affected product was not available for technical laboratory investigation of the manufacturer as the customer disposed of the hls set after patient treatment.Therefore, it is not possible to determine the exact root cause for the reported failure.However, the reported failure "problems reading pressures/temperature" can be linked to the following most probable cause according to our risk management file: -wrong pressure measurement due to malfunction of the pressure sensor -temperature sensor does not deliver accurate temperature data based on the investigation results it was not possible to confirm the reported failure "problems reading pressure/temperature".The production records of the affected hls module were reviewed on 2023-02-10 for the reported failure.According to the final test results, the affected hls module with udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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 : 4115.

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: 16049765
• MDR Text Key: 306351096
• Report Number: 8010762-2022-00527
• 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
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000240856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1