MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was a leakage on the gas outlet of the hls set.The failure occurred during treatment.There was a big leakage of water (200-300ml), therefore the device was exchanged.The incident affected the patients oxygenation and therefore influenced the treatment.Complaint id# (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The event occurred in germany during treatment.It was reported that there was a high amount of leakage of water (200-300ml) on the gas outlet of the hls set.The device was exchanged, cleaned and sent to manufacterer.The incident affected the patients oxygenation and therefore influenced the treatment.As this incident influenced the treatment a report is required.The affected hls set has been returned to the manufacturer for investigation, however the information that the involved patient was actually infected with influenza was not provided to us in upfront when asking for documents for return.When receiving the product including the return documents (declaration of infection risk) we were informed about the infection by document.According to getinge procedure to protect the employees of any infection the affected set was disposed as a precautionary measure and therefore no technical investigation could be performed.A medical review was performed by getinge medical affairs on (b)(6) 2024 with following conclusion: following the description of the complaint narrative, the affected patient was treated with a vv-ecmo (cardiohelp-i with an hls set advanced 7.0) starting from (b)(6) 2024.A hu 35 was utilized as the heater cooler unit.On january 22, 2024, the described event occurred.Initially, there was an accumulation of fluid beneath the oxygenator, which subsequently dripped from the gas outlet.Approximately one to two hours later, the hu 35 began alarming that the fluid level was too low.The hu 35 was turned off, refilled with ampuwa, and restarted.Subsequently, water leaked in larger quantities from the gas outlet until the hu 35 was depleted again within a few minutes.Additionally, the measured blood oxygen saturation of the affected patient decreased.For safety reasons, the set was replaced.Since the patient was diagnosed with influenza infection, the affected set was disposed of as a precautionary measure without further investigation.According to the customer, the hu 35 had to be refilled once, and subsequently lost so much fluid through the gas outlet within a few minutes that it alarmed again.According to the instructions for use (ifu), the difference between maximum and minimum fluid levels is 0.7 liters.Therefore, it can be assumed that at least this much fluid was lost if the water was refilled to the maximum level (markings) as indicated on the product.The customer also reports that the fluid leakage occurred only at the ¿condensation water outlet¿ (gas outlet) of the oxygenator.Because a considerable quantity of liquid was observed at the gas outlet, the assumption is that condensation may be ruled out.Hence, it is possible that a leakage between the gas and water compartments within the oxygenator was the probable root cause.Following the assumption of a leakage between the water and gas side, gas exchange may be impaired, leading to a decrease in blood oxygen saturation in the patient since the diffusion pathway for the gas is infiltrated with water of the hu 35.Whether the leakage existed before the described event cannot be completely discerned, as the customer unfortunately did not respond to question 7 of the questionnaire whether a tightness test (i.E., using the water heater (hu35)) was performed before using/priming the product.As a note, the questionnaire stated that no leakage was observed during and after the priming process.Ultimately, it is possible that some form of leakage between the gas and water sides of the oxygenator was present.To capture possible breaches before application, the product ifu recommends that a leakage test should be conducted on the oxygenator prior to priming (i.E., using the water heater (hu35)).This procedure is also documented in the instructions for use (ifu) in ¿7.2 priming the system¿.The answered questions 7 and 8 of the questionnaire does not fully clarify how this recommendation was carried out in this case.Based on the description of the event in the complaint narrative, a leakage between the gas and water phases of the membrane may have been present.Further, the probable leakage may have contributed to an observed malperformance of the product, as the gas transfer was reported as impaired.Despite the suspected water leakage within the hls module, a definitive root cause and/or location cannot be established without direct examination of the product.While possible, it is unclear if the influenza reported by the in the complaint narrative was either intrinsic to the patient (i.E., present before extracorporeal support) or the result of the possible malperformance.That said, the presence of blood in the leakage was not reported; therefore, it is assumed that a breach of the heat exchanger fiber bundle was unlikely and that the possible nonconformance was isolated to the fluid path.Last, given the content of the complaint narrative and subsequent correspondence, it remains unclear if the reported leakage may have been detected prior to extracorporeal support via confirmation of product integrity as recommended in the product ifu.The production records of the affected product were reviewed on 2024-05-13.According to the final test results, the modul with lot#3000346506, lot#3000346504 and lot#3000348184 passed the tests as per specifications.Production related influences are unlikely.The review of scrap, rework, enhancements, design changes, capa, field actions, non-conformance data were reviewed an no abnormalities in regards to the reported failure were found.Based on the investigation results the reported failure could not be confirmed in order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-460 version 01 chapter 7.2 priming the system - check the device for leaks during priming.- do not use the device if there are any leaks.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.

• Brand Name: HLS SET ADVANCED 7.0
• 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: 18580888
• MDR Text Key: 333739079
• Report Number: 3008355164-2024-00003
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2024
• Distributor Facility Aware Date: 04/24/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR