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 Pressure Problem (3012); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

It was reported that the internal pressures read zero,then the customer wiggled the hls cable and it came up to 747.The getinge technician confirmed that the hls cable was not the problem, it was the hls set itself.The hls set is available for investigation.The failure occurred during treatment.The hls set was not exchanged during treatment.No harm to any person was reported.(b)(4).

Manufacturer Narrative

The affected hls set will be sent back for investigation.A follow-up emdr will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the internal pressures read zero, then the customer wiggled the hls cable and it came up to 747.The getinge technician confirmed that the hls cable was not the problem, it was the hls set itself.The failure occurred during treatment.The hls set was not exchanged during treatment.The hls set was investigated in the getinge laboratory on 2022-07-29.After multiple wingling and connection/disconnection of the hls cable the values were still constant.The visual inspection does not show any damages.A technical failure according to the hls set can be excluded.Therefore the failure could not be reproduced.However, the most probable root causes according to the investigation results are: damaged connection socket.User error.The production records of the affected beq-015703112 #shls module advanced adult with packaging lot#3000191318 were reviewed on 2022-08-04.According to the final test results, the hls module with lot#3000191318 and udi# (b)(4) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.According to the instruction for use hls set advanced 5.0/7.0, hit set advanced 5.0/7.0|11| in chapter 4.3.1 safety instructions for the oxygenator it is mentioned that the pressure drop has to be monitored and the hls set advanced has to be replaced if the pressure drop is significant.Based on the results the reported failure "pressure reading zero" could not 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: 14789088
• MDR Text Key: 303247967
• Report Number: 8010762-2022-00240
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/24/2022
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000195062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Female
• Patient Weight: 542 KG