MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP PLUS); CATHETER, CONTINUOUS FLUSH

Model Number T001691A

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

It was confirmed that the device was not available for evaluation as it was discarded by the facility.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.The exact lot number was unknown, therefore review of the manufacturing records could not be completed.Per the ifu, poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Abnormal pressure readings should correlate with the patients clinical manifestations.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

Event Description

As reported, during use in patient of a disposable pressure transducer (dpt) with vamp, the patient started to be hemodynamically unstable after a ct scan was performed.The systolic blood pressure measured 200 mmhg and therefore norepinephrine infusion was stopped and nitroin (nitroglycerin/glyceryl trinitrate) infusion was administered to lower the blood pressure.After 30-40 minutes, it was identified that the device was damaged by the ct scan which caused errors in the measurement.The device was replaced and the systolic pressure measured 67 mmhg.The nitroin infusion was stopped, norepinephrine was resumed and the patient stabilizes again.No signs of irregular heartbeat or anything else that might indicate the result of patient failure.Patient demographics were requested but were not provided.

Manufacturer Narrative

Further information was provided.After completing a ct scan in patient, this dpt with vamp displayed systolic blood pressure value of 200 mmhg because the dpt black plate had been broken.Customer did not noticed the breakage of the device, that may have happened as per user report, during patient transport for a ct scan or because the device was crushed between the patient bed and ct table.Therefore, norepinephrine infusion was stopped and nitroin (nitroglycerin/glyceryl trinitrate) infusion was administered to decrease the blood pressure to normal values.However, blood pressure continued to be high and unstable, so user started to suspect about the faulty dpt.The dpt was replaced by another one and systolic pressure value was low (67mmhg), probably due to nitroin infusion.Then, nitroin infusion was stopped and noradrenaline was administered; after 15 minutes patient was stabilized again.This was a patient with pre-existing brain damage.Additionally, model number of the device involved, and patient demographics were provided.

Manufacturer Narrative

Upon further review, it was determined that the health effect - clinical code should be updated to reflect the patient outcome.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP PLUS)
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12433353
• MDR Text Key: 270104503
• Report Number: 2015691-2021-05040
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001691A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 36 KG