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

Model Number PX260

Device Problem Incorrect Measurement (1383)

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

Event Date 12/17/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this disposable pressure transducer, the mean arterial pressure (map) was inaccurately provided.No error message was displayed and the patient was not treated according to the inaccurate values.Patient demographics unable to be obtained.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

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

Added: d4 (expiration date), d8 (was this device serviced by a third party?), h4 (device manufacturer date) updated: h3 (device evaluated by manufacturer).The disposable pressure transducer (dpt) involved in this case was sent to our product evaluation laboratory for a full evaluation.As received, customer report of pressure value issue was confirmed.Dpt did not zero nor sense pressure on pressure monitor.Electrical testing showed that input impedance was within specifications, but output circuit was open condition.Crack was observed on sensor chip inside the dpt.Crack run across entire sensor chip and affected output circuit.No visible damage/defect was observed at solder joints, dpt cable connector, and cable of dpt.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Further investigation was provided by the engineers in the manufacturer site.As per current investigation, there is no evidence to conclude that the reported issue could be caused during the manufacturing process, since there are stablished process controls to prevent the occurrence of the reported malfunction.A potential root cause could be associated to supplier, since this condition could be found in the sensor chips before the assembly of the sensor to the cable and there are instructions to perform a visual inspection for this condition before starting the operation.However, this type of condition will continue being monitored through the complaint system for track and trending and actions determination as applicable.A supplier notification was provided through the supplier quality team.Edwards will continue to review and monitor all events.

• 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: 18474345
• MDR Text Key: 332428618
• Report Number: 2015691-2024-00177
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX260
• Device Lot Number: 64808039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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