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

Model Number T100209B

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that when this pressure monitoring set was connected after the placement of an arterial catheter in a patient, the blood pressure was ¿discordant.¿ the blood pressure was verified with the arm cuff and there was a difference of 150 mmhg.The problem solved after changing the blood pressure sensor.There was no allegation of patient injury reported.Device was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

Per follow-up, it was confirmed that there were no alarms or error messages and no deviation from normal operating procedures when using the dpt.It was clarified that the original sensor was exchanged as it was positional and not due to a non-conformance.The value provided by the new sensor was bp 6/3.The expected value was 12/7, which was the value of first positional arterial sensor.The bp on the cuff was the same as the old sensor: ¿tas 12¿.The patient was not treated according to the values provided by the new sensor.They exchanged the dpt set and the patient's bp was ¿tas 12¿, which was the expected value.Patient data are: initials pg, 34-year-old woman, 65 kg.

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of pressure measurement issue was not confirmed.The dpt zeroed and sensed pressure accurately on a pressure monitor.The pressure did drift during output drift testing but met specification.Electrical testing showed that both input and output impedance were within specifications.No leakage or occlusion was detected from the kit during the pressure test.No visible damage was observed from the kit.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.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.Pressure readings should correlate with the patient¿s clinical manifestations.In this event, there was no patient compromise noted.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 part of this monthly review.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 9555785
• MDR Text Key: 188674458
• Report Number: 2015691-2020-10050
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: T100209B
• Device Catalogue Number: T100209B
• Device Lot Number: 62396559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/15/2020; 02/06/2020; 07/23/2020
• Supplement Dates FDA Received: 02/03/2020; 02/21/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 65