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

Model Number HLS SET

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.H3 other text : device already discarded by customer.

Event Description

It was reported that there was a blood leak and one of the 3 stopcocks has a crack on the bottom.The failure occurred during treatment.The consequence for the patient is a loss of hemoglobin of 7.5 tp 6.7 g/dl.This required the provision of cgr.The hls set was discarded by the customer.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that there was a blood leak and the valve has a crack on the bottom.The failure occurred during treatment.The consequence for the patient is a loss of hemoglobin of 7.5 tp 6.7 g/dl.This required the provision of a transfusion.The hls set was exchanged.The hls set was discarded by the customer.Further it was reported that the affected hls set was initially used for four days without any malfunction.On 2024-02-22 the information was received that the customer will not provide further information.A medical review was performed by getinge medical affairs on 2024-03-08 with following conclusion: "the very sparse complaint narrative describes the development of a leak, presumably at one of the luer-lock connectors on the hls-set intended for blood sampling ("quick vent" luer lock connector, luer lock connector "arterial sampling", "venous sampling" luer lock connector).The answers provided to the questions posed by the dcu to the customer could not identify the exact site of the leak.As the french ¿robinet¿ can be translated into various synonyms for closable apertures, it might exclude the true-bored luer-connectors present on the hls-module.The answer to the question ¿was the crack on the three-way valve?¿ suggests that a three-way-stopcock by another supplier may have been utilized.The answer: ¿not on the 3 way faucet, the faucet had a crack on the lower part.¿ suggests the damage may have been to the hls-housing at the luer-connector.Regardless, the customer¿s responses appear to disagree with each other, leading to difficulty arriving at a clear determination of the origin of the nonconformance given the limited information provided.Assuming the defect to be present on the threaded female luer-connector of the hls module, it is unlikely that the defect was present from the beginning of support, as the set is checked, handled and monitored by the user during, set-up, priming and implantation, where a leak would have been detected.In the chapter 5.2 ¿safety instructions for the extracorporeal circulation¿, the hls-set ifu instructs the user to secure and check all connections and components before and during use.High torque/tension may have been applied unintentionally during fastening of the male-luer connector to the disposable.This is also possible during routine checks of the circuit by ¿re-tightening¿ or upon sudden/inadvertent tension exerted if lines are pulled during use.Given the assumption that the intra-system pressures and mechanical strain applied to the disposable are relatively constant during extracorporeal support, the development of a crack at the housing may be explained by the exertion of force onto the disposable sometime on day four.The accumulation of leaked blood then was detected and led to the exchange of the damaged hls-set.The dearth of information and the discarded disposable prohibits a further investigation into the exact position, nature, and/or origin of the defect.In conclusion, a definitive root cause could not be established given the available information.Further, considering the delay of 72-96 hours for the development or detection of the leak, a reasonable supposition may be that the product may have been damaged unintentionally during support while the product was used as a platform for continuous renal replacement therapy.Last, the blood lost by the patient which required the administration of packed red blood cells may have been associated to the event reported in the complaint; however, the severity (in terms volume lost) and duration of the leak, the disposition of the patient, and the details regarding the conduct of extracorporeal support are all unknown.Therefore, a clear determination of an association between the reported leak and the administration of packed cells cannot be established at the time of this review." referring to the instructions of use of the hls set (chapter basic safety instructions) it is stated to not use defective devices (example if device is damaged).In chapter ¿safety instructions for the hls set¿ it is further mentioned to check the set if its complete and not defective.Further chapter "preparation and installation" states to perform a careful visual inspection of the sterile packaging before use and to pay particular attention to moisture, openings and soiling.Additionally a careful visual inspection of the device before use should be performed.In particular, to ensure there is no damage to the material, cracks, burrs or fissures.¿ the production records of the affected product were reviewed on 2024-03-08.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 event "leakage - due to crack, patients hemoglobin low" could not be confirmed due to affected product was not made available for investigation and due to not providing all information by the customer.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: 18510119
• MDR Text Key: 332895297
• Report Number: 8010762-2024-00023
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Device Catalogue Number: 701069073
• Device Lot Number: 3000336489
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening