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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problems Contamination (1120); Device Sensing Problem (2917)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

The event occurred in hong kong.It was reported that a malfunction of the arterial pressure sensor was suspected during patient treatment.No clot was found on the oxygenator of the hls set and the flow was able to reach the target value.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.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that there was a reading failure of the arterial pressure.The failure occurred during treatment.No clot was found on the oxygenator of the hls set and the flow was able to reach the target value.The affected hls set was investigated by the getinge laboratory on 2023-06-21 with following conclusion: during visual investigation it was confirmed that both cable ties on the blood inlet were very loose.The arterial pressure sensor was not working during technical investigation.The most probable root cause is a faulty solder joint.The production records of the affected #shls module advanced adult were reviewed on 2023-06-12 for the reported failure.According to the final test results, the #shls module advanced adult passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "p-art wrong reading" could be confirmed.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.

• 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: 16271104
• MDR Text Key: 308951046
• Report Number: 8010762-2023-00057
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000228851
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1