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

Model Number PXMK10261

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 indicated central venous pressure on a phillips patient monitor was negative during use.No treatment based on the incorrect value was performed.The device was able to be zeroed before use.No data log was available.The device was not replaced.No other trouble shooting was performed.No occlusion, leakage or kink was observed.The expected values, if abnormal waveform was observed, if the pressure values matched the waveform, and if any error message was observed are unknown.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported event of pressure measurement issue was not able to be confirmed.Dpt zeroed and sensed pressure accurately on pressure monitor.Pressure did not show any drift during output drift testing.The initial pressure was 150 mmhg and final pressure was 149 mmhg, which met specification.Electrical testing showed that both input impedance, 2196 ohms, and output impedance, 299 ohms, were within specifications.Specifications were 1200 ohms to 3400 ohms for input impedance and 285 ohms to 315 ohms for output impedance.Zero-offset, neg.3 mmhg, also met specification.No visible defect was found from dpt cable connector.Further evaluation regarding related quality issues is under investigation.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

An engineering evaluation was completed and concluded that no device problem was found and no problem was detected.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

Per additional information from the sales rep, it was confirmed that the device was not replaced.The event was unexpected, as there was no factor that would result in getting a negative value.Further evaluation regarding related quality issues is under investigation.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 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16436939
• MDR Text Key: 310193026
• Report Number: 2015691-2023-11051
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2023

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 Model Number: PXMK10261
• Device Lot Number: XP0822MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/02/2023; 03/17/2023; 05/03/2023
• Supplement Dates FDA Received: 03/24/2023; 04/04/2023; 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1