MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER); TRANSDUCER, PRESSURE, SINGLE USE

Model Number PX260

Device Problem Contamination (1120)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.In addition, piece that fell from device pressure tubing was lost and was not available for evaluation.Upon the return of the product a supplemental report will be sent with the investigation results.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, when replacing before use in patient the pressure tubing of this disposable pressure transducer, a round piece of plastic of the same size and material came out from the luer.The piece fell on the floor and could not be found.There was no allegation of patient injury.The device was available for evaluation but not the lost foreign material.Patient demographic information was not available.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER)
• Type of Device: TRANSDUCER, PRESSURE, SINGLE USE
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19152922
• MDR Text Key: 341461833
• Report Number: 2015691-2024-03053
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 07460691950191
• UDI-Public: (01)07460691950191(17)250914(11)230915(10)65311143
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

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 Model Number: PX260
• Device Lot Number: 65311143
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2023
• 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