MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001657A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Death (1802)

Event Date 08/23/2020

Event Type  Death  

Manufacturer Narrative

Based on expert report performed by dr.(b)(6) (courtesy of hm coroners office) there is no reason to believe that the pressure transducer kit was faulty or included a defect through which air entrained.The transducer kit has been retained by city of (b)(6) hm coroner and is not available to return to edwards for evaluation.Attempts are being made to obtain a copy of the coroners report for further information.Without the device the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with additional information once received.

Event Description

On (b)(6) 2020 a patient had undergone cardiothoracic surgery and was recovering normally on (b)(6) 2020.The patient was no longer mechanically ventilated and was neurologically intact.On (b)(6) 2020 at the beginning of the shift, 20:00 shift start time, the pressure transducer was checked, a visual assessment was made of the remaining level of fluid in the transfusion bag (while in the pressure bag), and that there were no leaks from the equipment and all connections were secure.At 0430 in the morning an arterial blood gas was taken from a radial artery line that had a connected pressure monitoring set.The nurse reported that there were no visible air bubbles in the line and that it was difficult to flush the line and that some residual blood had remained in the line.At the time, the waveform was present, arterial line trace and cvp trace were giving accurate values.About 15 minutes after the sample was taken and was flushed via the integrated toggle the bedside monitor alarmed and the arterial waveform was absent.The nurse attempted to flush the line via the blue toggle but there was no fluid flow and no change.An attempt to aspirate blood from the arterial line was made but no blood was drawn.An attempt was made to aspirate fluid from the bag with a syringe and it was noted that the pressure bag was deflated and re-inflated to 300mmhg.The blue toggle was pulled but with no return of the arterial waveform.The nurse noted that there was no fluid from the drip chamber and then realized that the infusion bag was empty.Before having time to change the bag the patient started mumbling and was not responding.The emergency team was called.The patient suffered associated sudden deterioration in conscious level and despite all critical care interventions the patient died.A ct head showed multiple intracerebral air embolism and the diagnosis of brain stem death was made.The cause of death was noted as air embolism by the post mortem report.Despite extensive investigation of all possibilities the investigation was unable to establish the root cause for the mechanism of how air was introduced into the patient.Following the patients death the transducer was retained and surrendered to the hm coroner.

Manufacturer Narrative

This complaint failure was unable to be confirmed, as the device was not returned, neither photographs, videos, nor images were provided for further evaluation.Since the lot number was reported as unknown, it was not possible to review the device history record (dhr) and neither the lot history in order to identify the if there was any associated nonconformance registered during the product manufacturing process.As per assessment from ew product safety agrees with the coroner because it is not possible for air to enter a peripheral artery and result in a major cerebral air embolism without a radial venous fistula with an asd/vsd (atrial septal defects / ventricular septal defect) ; and also the physics make it a non-issue.It is standard clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.The ifu states: ¿do not allow air bubbles to enter the setup, especially when monitoring arterial pressures.¿? ¿if all air is not removed from the bag, air may be forced into the patient¿s vascular system when the solution is exhausted.¿? ¿significant distortion of the pressure waveform or air emboli can result from air bubbles in the setup.¿? ¿periodically check fluid path for air bubbles.?, after each fast-flush operation, observe the drip chamber to verify that the continuous flush rate is as desired.Ensure that connecting lines and stopcocks remain tightly fitted.¿? air emboli is a stated complication in the ifu.? invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is unknown whether user or procedural factors played a role in this event.

Manufacturer Narrative

The coroners report was obtained for a 2020 case of the female that had undergone mitral and aortic valve replacement cardiac surgery during which the patient was monitored with an edwards dpt post-operatively.The cause of death was noted to be: global hypoxic brain injury, air embolism, and heumatic heart disease.Based on expert report by the coroners office, there is no reason to believe that the pressure transducer kit was faulty or included a defect through which air entrained.The hospitals investigation was unable to conclude a definitive root cause.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 10980631
• MDR Text Key: 220575705
• Report Number: 2015691-2020-14935
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: T001657A
• Device Catalogue Number: T001657A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 05/06/2022
• Supplement Dates FDA Received: 12/22/2020; 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 48 KG