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

Model Number HLS SET ADVANCED

Device Problems Pressure Problem (3012); Temperature Problem (3022)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

It was reported that there was an arterial pressure sensor issue (p-art).Further information was received that the internal pressure (pint), arterial pressure (p-art) and the arterial temperature (t-art) were intermittent displayed.The hls cable of the cardiohelp device was replaced without solving the failure.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that there was an arterial pressure sensor issue (p-art).Further information was received that the internal pressure (pint), arterial pressure (p-art) and the arterial temperature (t-art) were intermittent displayed.The hls cable of the cardiohelp device was replaced without solving the failure.The failure occurred during treatment.The affected product was investigated in the getinge laboratory on (b)(6) 2023 with following conclusion: the reported failure could be confirmed.The traces of corrosion indicate electrochemical corrosion of the electronic components.This type of corrosion occurs when an electrolyte such as saline or general priming fluid is involved.If an electrical voltage is applied, the corrosion process is accelerated.The corrosion and the resulting damage and deposits can affect the electronics and lead to the total failure of electronic components.According to the instruction for use (hls set advanced 5.0/7.0, hit set advanced 5.0/7.0) in chapter 4.3.1 safety instructions for the heat exchanger is following stated: test the functioning of the temperature sensors before each use.Only use tested and approved temperature sensors.Furthermore it is stated in the instruction for use of the cardiohelp (ifu, cardiohelp system, chapter 9 messages) if the measured values are above high limit or below low limit of the set limits and if the sensor is defective the system generates a visual and acoustical alarm.To monitor the patient temperature the venous temperature is measured by the venous probe.Further in case of a failing arterial temperature sensor an external sensor can be connected (ifu, cardiohelp, chapter 5.3.3 connecting external temperature sensors).The production records of the affected product were reviewed on 2023-09-19.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 "no arterial temperature reading and pressure reading" could be confirmed.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: 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: 17235447
• MDR Text Key: 318216025
• Report Number: 8010762-2023-00316
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: 701068216
• Device Lot Number: 3000293725
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1