MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET 5.0 ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 5050

Device Problems Complete Blockage (1094); Gradient Increase (1270); Increase in Pressure (1491)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/30/2023

Event Type  Death  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.H3 other text : 4118.

Event Description

It was reported: second hls set exits after 10 hours of operation as va-ecmo.Rapid and continuous increase in the delta p value and simultaneous reduction in blood flow to almost 0 ltr/min.Sub-actual klotting.Planned change to the third set with alternative anticoagulation (agratoban) in case of suspected hit no longer takes place because the patient died before the change.First event for same patient reported under complaint id: (b)(4).

Manufacturer Narrative

The affected product was investigated by getinge laboratory on 2023-08-03 with following conclusion: during visual investigation of the product no damages were found.Further there were way taps from another manufacturer, which were connected to the luer lock on the blood out- and inlet side.No abnormalities were found during the functional tests.Therefore the root cause remains unknown.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).First event for same patient reported under complaint id: (b)(4) (mfg report number 8010762-2023-00199).

Event Description

Complaint id#(b)(4).First event for same patient reported under complaint id: (b)(4) (mfg report number 8010762-2023-00199).

Manufacturer Narrative

It was reported that there was high delta pressure, reduced flow, clotting and the blood flow was nearly 0 l/min.The failure occurred 10 hours after the first exchange of the hls set due to the same failure, which will be investigated in complaint# (b)(4) (mfg report number 8010762-2023-00199).Therefore the customer planned to exchange the hls set to a third hls set with an alternative anti-coagulation in suspicion of a heparin-induced thrombocytopenia.The patient expired before the third hls set was connected.The affected product was investigated by getinge laboratory on 2023-08-03 with following conclusion: during visual investigation of the product no damages and no clots were found.Further there were way taps from another manufacturer, which were connected to the luer lock on the blood out- and inlet side.No abnormalities were found during the functional tests.Therefore the root cause remains unknown.A medical review was performed by getinge medical affairs on 2023-09-28 with following conclusion: "when evaluating the correspondence and investigation reports, the customers complaint regarding the low-flow and pressure increase during the v-v ecmo run seems plausible (complaint (b)(4)) especially when considering that the cleaning procedure during the inspection and testing by the getinge laboratory had to be performed twice in order to clean blood and clot residues.However, it remains unclear, whether the observed clots upon inspection originate from the case or formed during transport due to the blood-filled tubing.After the exchange to a second, pre-primed hls-system the patient is suddenly described as being supported in a v-a ecmo configuration ¿ as no answers were received, the sudden change in support remains unclear.After 10 hours of v-a ecmo support the flow is reported to again be decreasing and pressures rising (complaint (b)(4)).The customer, suspecting a heparin induced thrombocytopenia type 2 (hit ii) contemplated another hls-system exchange, including a switch of anticoagulants from heparin to a direct thrombin inhibitor (argatroban).However, the patient expired prior to this.The root cause remains unclear.With the rapidity of progress in therapy escalation and without any answers to the questions pertaining to illness and coagulative state, it may be suspected that the clotting of the hls system contributed to the negative outcome but was not the root cause.After testing by the getinge laboratory the systems were found to generally be in working order.Altogether, the clotting of the oxygenator membrane may have been caused by insufficient anticoagulation, possibly exacerbated by hit ii which may have developed after prolonged exposure to heparin, as was suspected by the clinical team in complaint (b)(4).Therefore, it is challenging to attribute a product-related malfunction or diminution in performance to the product cited in both complaints." the production records of the affected product were reviewed on 2023-10-17.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 "decreased flow, high pressure" could not 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.

• Brand Name: HLS SET 5.0 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: 16866592
• MDR Text Key: 314524155
• Report Number: 8010762-2023-00200
• 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: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: BE-HLS 5050
• Device Catalogue Number: 701069076
• Device Lot Number: 3000255334
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 72 KG