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

Model Number HLS SET

Device Problem Noise, Audible (3273)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that noise was coming from the hls set.The hls set was connected properly.The customer stated that the patient was on for an extended time, and it was felt that the coagulation build-up was the cause of the noise.The cardiohelp will be investigated in complaint id # (b)(4).The failure occurred during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that noise was coming from the hls set.The hls set was connected properly and it was confirmed that there was no gap present between the cardiohelp and hls set.The customer stated that the patient was on for an extended time, and it was felt that the coagulation build-up was the cause of the noise.The cardiohelp was investigated in complaint id# (b)(4) (ref.Mw 8010762-2024-00163).On 2024-05-24, the fst confirmed that several communication attempts were done to retrieve information, but the customer was unresponsive.The failure occurred during treatment.No harm to any person has been reported.The affected product is not available for technical investigation as the hls set was discarded by the customer.However, the customer and the fst stated that the most probable root cause was coagulation built-up in the hls set which caused the noise.As stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, in the chapter ¿safety instructions for centrifugal pump¿, ¿leaks or scratching noises in the centrifugal pump can be a sign that it is malfunctioning.Malfunctioning can lead to inadequate patient support.Always keep a replacement hls set advanced at the ready.Listen for scratching noises when priming the system.Replace the hls set advanced if you hear scratching noises.In addition, in the chapter "safety instructions for the extracorporeal circulation" , it is indicated clearly that "no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.Use anticoagulants; e.G.Heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application, and check the coagulation status of the patient's blood regularly.The protocol for coagulation management is the responsibility of the user in charge.The review of scrap, rework, enhancements, design changes, capa, and field actions from the device history review could not be performed as the serial/lot number was not available.Nevertheless, the non-conformance data was reviewed an no abnormalities in regards to the reported failure were found.Based on the results, and the provided video, the reported failure "hls set noise" 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 : discarded.

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: 18959929
• MDR Text Key: 338368693
• Report Number: 8010762-2024-00155
• 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: 05/24/2024

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1