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

Model Number HLS SET

Device Problem Infusion or Flow Problem (2964)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477); Asystole (4442); Insufficient Information (4580)

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 loss of blood flow.The failure occurred during treatment.The nurse heard a ¿thud / thump¿ and something that sounded like an increasing in the rpm from the cardiohelp device.Consequently the patient suffered an acute desaturation, becoming bradycardic and eventually asystolic.It was only able to establish the flow of approximate 3.8l/min.There were no kinks in the line, no clots in the oxygenator and no cannula migration.The hls set was exchanged during treatment.Patient stabilized, flow established and saturation improved.The affected cardiohelp will be investigated in complaint#: (b)(4).Complaint id#: (b)(4).

Manufacturer Narrative

It was reported that there was a loss of blood flow.The nurse heard a ¿thud/thump¿ and something that sounded like an increasing in the rpm from the cardiohelp device.Consequently, the patient suffered an acute desaturation, becoming bradycardic and eventually asystole.The customer was able to establish the flow of approximate 3.8l/min.There were no kinks in the line, no clots in the oxygenator and no cannula migration.The hls set was exchanged during treatment.The patient stabilized, flow established, and saturation improved.The cardiohelp will be investigated in complaint# 870327 (mfg report number 8010762-2023-00388).The affected hls set was investigated in the getinge laboratory on 2023-11-22 with the following conclusion: the reported failure could not be confirmed.The associated tubing system and other components of the hls set were not included in the return shipment, therefore, only the hls module could be taken into account when processing the complaint.During visual inspection, no foreign bodies, tissue residues and/or other abnormalities that could have a negative effect on a constant (through) flow were observed.There were no anomalies during the flow test.In addition, the required flow values were set and achieved without any problems and plausible pressure values were read throughout the test.Therefore, the most possible root cause could be a possible damage/kink on the tubing set.A getinge field service technician (fst) was sent for investigation and repair on 2023-08-15 for the cardiohelp device.The hls cable was corroded and the customer was asked to replace it.The corroded hls cable has not affected the device function and was discarded.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A medical review was performed by getinge medical affairs on 2023-11-29 with following conclusion: "the customer questionnaire reported that the patient was administered bilvalirudin (0.075 mcg/kg/hr) during support as an anticoagulant/direct thrombin inhibitor (dti).However, no details were divulged as to why bilvalirudin was chosen over heparin.It is assumed that the choice of bilvalirudin may have been chosen due to heparin induced thrombocytopenia (hit) or similar coagulatory/hematologic pathology, but no background behind the choice of the dti was provided by the customer.The d-dimers reported by the customer were 2.21 ng/ml which is a signal for clotting.However, the elevated d-dimers may not have been sufficient to signal thrombus formation in the membrane.Calculation of o2 transfer across the membrane is unable to be performed due to the lack of an svo2 in the customer questionnaire.A low o2 transfer value may indicate the presence of thrombus in the membrane relative to the o2 transfer (and implied co2 removal) due to the reduction of available membrane area.Regardless, the d-dimer values reported by the customer appears to signal the presence of forming/active thrombus.One possible root cause of the event reported by the customer (¿thud¿) may have been the acute aspiration of thrombus (e.G., deep vein thrombus) from the patient into the centrifugal pump rotor.This may explain the "thud/thump" that was accompanied with the corresponding rpm whirring heard by the attending clinician.A second possible root cause of the event may have been associated with hypovolemia and/or inflow cannula restriction.Cannula restriction may have manifested as adherence to the vessel wall and then detachment upon administration of intravenous fluids.Fluid administration may explain the elevation in blood pressure, decrease in pven, decrease in rpms and increase in blood flow post event.That said, few details were provided by the customer, so a definitive analysis is not able to be performed.According to a study by moffett and teruya, aptts are ¿poorly correlated with other tests of dti activity¿, unlike ecarin clotting time.Therefore, measurement of aptt alone may not have adequately reflected the condition/status of a dti to prevent thrombin formation.This may lend support to either a possible patient-related or an anticoagulation-related root cause.As a note, no mention of dti testing was made in either the complaint narrative or the follow-up questionnaire; therefore, it is assumed that no dti testing for (e.G., ecarin clotting time) was performed.The service report stated that the cardiohelp console passed function testing.Further, the getinge investigation of the disposable lead to the following conclusion "it should be noted that the flow reduction complained about by the customer cannot be confirmed from a technical perspective.None of the tests carried out revealed a reduction in flow through the hls module.The condition of the associated tubing set / hose system could not be checked and taken into account during the test.Any damage such as kinks or other deviations can, under certain circumstances, result in a reduction in flow in the system or have a negative impact on the flow." therefore, it is challenging to assign a root cause of the event to the product.If the kink-guard was removed, kinking, or bending, of the tubing directly before the inlet of the disposable may have contributed to a low flow state thereby creating an environment for thrombus formation.Barring more evidence from the customer regarding the event, the possible root cause for the event explained by the customer may be more likely patient-related than product-related.Last, a clot/thrombus in the pump rotor of the hls disposable would have affected the ability of the pump drive to maintain adequate blood flow, which likely led to the acute desaturation explained by the customer (i.E., barring the contribution of patient comorbidities to an acute desaturation)." according to the instructions of use of the hls set (chapter safety instructions for centrifugal pump) it is stated that to listen for scratching noises when priming the system and to replace the hls set advanced if there are scratching noises.The production records of the affected product were reviewed on 2023-11-22.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 "loss of blood flow and less oxygenation" could not be reproduced and was narrowed down as not product related.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: 17511766
• MDR Text Key: 321047170
• Report Number: 8010762-2023-00389
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 701069065
• Device Lot Number: 3000317530
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention