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

Model Number VO4602TWPL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

One flothru dpt kit without iv set and pressure tubing was received for evaluation.The reported event of pressure measurement issue was confirmed.The dpt with blue indicator did not zero nor sense pressure on pressure monitor.Electrical testing for dpt with blue indicator showed that both input impedance and output impedance were within specifications.However, the zero-offset value of dpt with blue indicator was unstable.Black marks/residue were observed on sensor chip inside dpt with blue indicator.No leakage was observed from the entire kit during leak test.Dpt with red indicator zeroed sensed pressure accurately on pressure monitor.Pressure for dpt with red indicator did not show any drift during output drift testing and met specification.No visible defect was found from dpt cable connectors.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 a part of the monthly review.

Event Description

It was reported that the left ventricle pressure value and aortic pressure value were inaccurate on the first day of use.The values shown on the monitor were 110 mmhg for lv and 120 mmhg for ao.Expected aortic pressure value was lower than 110 mmhg.There was no problem with shape of pressure waveform.The value and the waveform matched.The patient was not treated based on the incorrect value.Dpt zeroed before use.The data log was not provided.The device was not exchanged and the customer did not perform anything for trouble shooting.No error message was shown.Occlusion, leakage or kink on the device were not observed.A nihon kohden patient monitor was used.There were no patient complications reported.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with disposable pressure transducers can also be a contributing factor to inaccurate values.In regards to the pressure tubing, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether user or procedural factors contributed to the stated event.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.

Manufacturer Narrative

Although it was originally reported that this was a confirmed event however further evaluation indicated that the event could not be replicated and therefore is not a confirmed event.This product is manufactured by a third party manufacturer and as part of the assessment performed to this issue, (b)(4) was issued to the third party manufacturer addressing the malfunction dpt housing - sensor chip damaged.

• 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: 10996435
• MDR Text Key: 223207452
• Report Number: 2015691-2020-14994
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

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 Model Number: VO4602TWPL
• Device Lot Number: NK1834MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 01/19/2021; 03/24/2021
• Supplement Dates FDA Received: 02/12/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Weight: 37