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

Model Number HLS SET

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the arterial port was leaking and the customer changed out the circuit.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

It was reported that the arterial port was leaking and the customer changed out the circuit.The blood leakage was shortly noticed after an urgent initiation on a patient.The hls set was exchanged to a centrimag.The hls set was primed for 55 days.We have also been informed later by ssu that the hls set was primed for 55 days.That means the hls set was primed for 55 days before the leakage was identified.The affected product was investigated in the getinge laboratory on 2024 (b)(6) with following conclusion: the hls set was primed for 55 days and was than connected to the patient.Additionally, a third party cap was used on the luer connector.The failure of the leakage could be confirmed, a crack in the connector was identified.The hls set has an authorized operating time of 6 hours in the usa.Referring to the instruction for use (ifu, hls set advanced 6.0/7.0, hit set advanced 5.0/7.0) it is stated in chapter ¿priming the system¿ not to pre-prime the circuit too early as this could lead to leaks and to not use a device if there are any leaks.Furthermore, according to the instruction for use of the involved cardiohelp device (chapter 2.1.1 ¿indications for use¿) the cardiohelp system in configuration with the hls set advanced is intended to be used within the hospital environment and outside the hospital environment for periods up to six hours.The production records of the affected product were reviewed on 2024-02-01.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 "leakage of the arterial port¿ could be confirmed, but the hls set is registered in the us for 6 hours.According to the information it was primed for 55 days.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.

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: 18090571
• MDR Text Key: 327606879
• Report Number: 8010762-2023-00549
• 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: 02/01/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1