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

Model Number PXVPL0097

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

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.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.No corrective 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 a 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.There was no patient compromise noted in this event.It is unknown whether user or procedural factors played a role in this 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 part of this monthly review.The 510k is not known as this is a custom defined product.

Event Description

As reported, during use of this disposable pressure transducer combo kit, variances in invasive blood pressure (ibp) and non invasive blood pressure (nibp) were observed.Systolic differences were as much as 30mmhg.The line was checked and no abnormalities were observed.A square wave test showed a normal trace and no alarm was displayed.A print out of the pressure was carried out to verify the pressure waveform, which was found to be ¿overshooting¿.The patient was not treated due to the inaccurate values nor was patient injury reported.The patient was post coronary artery bypass grafting.Complete patient demographics were not able to be obtained.Unfortunately, the device was not available as the hospital discarded the device after removal.

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: 8051498
• MDR Text Key: 128443211
• Report Number: 2015691-2018-04591
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2020
• Device Model Number: PXVPL0097
• Device Catalogue Number: PXVPL0097
• Device Lot Number: 61328765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1