MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001724A

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

The pressure monitoring set involved in this case was received by our product evaluation laboratory for a full evaluation.As received, the iv tubing was cut and drip chamber was not returned.The dpt sensor zeroed and sensed pressure accurately on the pressure monitor.The pressure did not show any drift during output drift testing and met specifications.Thn, electrical testing showed that both input impedance and output impedance of the dpt sensor were within specifications.The zero-offset also met specifications.No leakage or occlusion was detected on the dpt sensor during pressure test.No other visible damage was observed on the the dpt kit.An engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.The lot number was not provided.Therefore, the device history record (dhr) could not be reviewed.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.

Event Description

As reported, during use in patient, this pressure monitoring set indicated an underestimated systolic and very underestimated diastolic values.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Based on further information received visual and audible alarms were displayed from the bedside monitor when the pressure monitoring set indicated underestimated values.If a machine alarms, the clinician is alerted of a potential issue and will trigger the clinician to conduct routine trouble shooting.In this case the bedside monitor alarmed in conjunction with inaccurate values displayed, therefore there is minimal risk for injury.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18353986
• MDR Text Key: 331187637
• Report Number: 2015691-2023-18519
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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: T001724A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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