MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; PRESSURE MONITORING KIT

Model Number PXMK10463

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

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 while using the disposable pressure transducer, the blood pressure value was inaccurate.Value shown on the monitor was over 300mmhg.No additional information about the incident is available.The device was exchanged and the problem was solved.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One flothru dpt with stopcocks and pressure tubing were returned for examination.The reported event of pressure measurement issue was confirmed.The dpt did not zero or sense pressure on a pressure monitor.Electrical testing showed that that the input impedance met specification, but the output circuit had an open condition.No visible damage was found at the dpt cable connector, sensor chip or solder joints of the dpt.Continuity testing confirmed that leadwires were continuous between the dpt cable connector and the cable near the dpt.The open condition was located between the #3 solder joint and the cable.Electrical testing from the solder joints showed that both input and output impedance were within specification.The above electrical evaluation suggested that the issue was within the dpt cable.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 patients 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

The reported event was concluded to be supplier related.The supplier was notified of the issue and the scar-001549 was generated to deeply investigate the dpt cable / broken leadwire condition at the supplier facility.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.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11393111
• MDR Text Key: 234040626
• Report Number: 2015691-2021-01602
• 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: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2022
• Device Model Number: PXMK10463
• Device Lot Number: NS0954MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1