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

Model Number HLS SEZ

Device Problem Pressure Problem (3012)

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

Event Date 02/10/2024

Event Type  malfunction  

Event Description

The event occurred in the usa during treatment.It was reported that the arterial pressure stopped functioning on hls set during use.Hls was set up and primed day of use.The set was used for several hours prior to the failure.Later all pressures, delta p and arterial temperature was not displayed.The customer did not exchange the set, the set was used without pressures.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the arterial pressure stopped functioning on the hls set during use.The hls set was set up and primed on the day of use.The set was used for several hours prior to the failure.Later all pressures, delta p and arterial temperature were not displayed, as shown on the provided pictures.The customer did not exchange the set, the set was used without pressures.The affected product is not available for technical investigation as the hls set was discarded by the customer.However, according to the hls set risk assessment, the following root causes can lead to both of the reported failures: - damage of the electrical sensors due to condensed water on the flexible circuit board - the user didn´t perceive or recognize how to plug the integrated sensor cable to the hls module or was not able to connect the integrated sensor cable to the hls module.The exact root cause remains unknown.According to the instruction for use ( hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.3, chapter preparation and installation) the pressure sensors have to be checked before priming.Further the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.In the instruction for use of the hls set in chapter ¿safety instructions for the oxygenator¿ it is stated that the temperature sensors have to be checked before each use.Further in case of a failing arterial temperature sensor an external sensor can be connected (instruction for use of the cardiohelp (ifu), chapter 5.3.3 "connecting external temperature sensors").The production records of the affected product were reviewed on 2024-02-27.According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "pressure and temperature reading issue" 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.H3 other text : device already discarded by customer.

• Brand Name: TUBING SET
• 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: 18796065
• MDR Text Key: 336408397
• Report Number: 8010762-2024-00109
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SEZ
• Device Catalogue Number: 701069078
• Device Lot Number: 3000349796
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1