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

Model Number BE-HLS 7050

Device Problem Device Sensing Problem (2917)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The product was requested for return to the manufacturer but was not yet received.The investigation of the manufacturer is ongoing.(b)(4).

Event Description

It was reported that the arterial pressure was not measured by the hls oxygenator during patient treatment.The display shows dashes (---).The cable and the cardiohelp device were replaced but still did not measure.After 24 hours, the value was measured for 2 hours, then it was not measured again.The arterial pressure was disabled at the cardiohelp device due to this.The product was not exchanged.No external pressure sensor was used to monitor the arterial pressure instead.No harm was reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the arterial pressure was not measured by the hls oxygenator during patient treatment.The display shows dashes (---).The cable and the cardiohelp device were replaced but still did not measure.After 24 hours, the value was measured for 2 hours, then it was not measured again.The arterial pressure was disabled at the cardiohelp device due to this.The product was not exchanged.No external pressure sensor was used to monitor the arterial pressure instead.No harm was reported.The affected product was technically investigated at the laboratory of the manufacturer.No external damage was found during an initial visual inspection of the hls module that was the subject of the complaint.Furthermore, no other damage was detected on the electrical components.During a functional test of the sensor no venous pressure was measured at all and the arterial pressure sensor did malfunction (no value) for 3 seconds.After drying of the hls module the arterial pressure was also not measured.Since no external damage could be found on either the flexible conductor or the hls connector, the most probable cause of the reported failure could be an electronic malfunction of the pressure sensor itself.Getinge will perform additional investigation.The investigation is still ongoing.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in czechia.The following complaint information was provided to maquet cardiopulmonary: "connected (b)(6) 2022 did not measure arterial pressure (---), cable replacement, device replacement, still did not measure after 24 hours, measured for approx.2 hours, then did not measure again, this happened again, disconnected on (b)(6) 2022, patient is fine at sukl not reported" the affected product was technically investigated at the laboratory of the manufacturer.No external damage was found during an initial visual inspection of the hls module that was the subject of the complaint.Furthermore, no other damage was detected on the electrical components.During a functional test of the sensor no venous pressure was measured at all and the arterial pressure sensor did malfunction (no value) for 3 seconds.After drying of the hls module the arterial pressure was also not measured.After uncovering the arterial sensor, contamination, oxidation and corroded soldering points could be determined.This type of corrosion occurs when an electrolyte such as saline solution or priming fluid, in general, is involved.If an electrical voltage is applied, the process of corrosion is accelerated.The corrosion and the resulting damage and deposits can impair the electronics and lead to the total failure of the electronic components.Thus a confirmation of the reported failure "did not measure arterial pressure" was possible.The exact root cause remains unknown.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: 15852694
• MDR Text Key: 304202334
• Report Number: 8010762-2022-00466
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701069073
• Device Lot Number: 3000210627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1