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 03/01/2021

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 this disposable pressure transducer, the values were inaccurate.The values shown on the monitor were over 300mhg right after the device was connected.The device was exchanged and the problem was solved.Patient demographic information was requested but it is unavailable.There were no patient complications reported.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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

One flow thru dpt sensor with pressure tubing was returned for evaluation.The reported event of inaccurate values was not able to be confirmed, as the monitor did not recognize the dpt sensor and no initial pressure value was shown on the pressure monitor.Dpt did not zero nor sense pressure on the pressure monitor.Electrical testing showed that input impedance and output circuits were open conditions.No visible damage was found at dpt cable connector, sensor chip or solder joints of dpt.Continuity testing confirmed that leadwires were continuous between dpt cable connector and cable near dpt, but open condition between #3 and 4 solder joints and cable near dpt respectively.Input and output circuits on sensor chip were continuous.Above electrical evaluation suggested that the issue was within dpt cable.X-ray evaluation showed #4 leadwire of input circuit and #3 leadwire of output circuit were completely broken inside dpt cable within potting area of dpt housing and created open condition.Since the part was manufactured at the supplier facility, the scar-001549 was generated to deeply investigate the dpt cable / broken leadwire condition at the supplier facility.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.It is not known if user or procedural factors may have contributed to the stated event.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.

• 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: 11411295
• MDR Text Key: 245464217
• Report Number: 2015691-2021-01652
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 03/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1