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 Insufficient Information (4580)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

The disposable pressure transducer (dpt) involved in this case was received by our product evaluation laboratory for a full evaluation.During the evaluation, the dpt zeroed and sensed pressure accurately on a pressure monitor.Pressure did not show any drift during output drift testing and met specifications.Then, electrical testing showed that both input and output impedance were within specifications.The zero-offset also met specifications.No visible defect was found on the dpt cable connector.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 in an emergency resuscitation situation, this disposable pressure transducer (dpt) connected to a radial artery provided incorrect blood pressure value of 56mmhg.Pulmonary artery pressure was measured correctly by another device connected to the femoral artery.There was no error message displayed.Expected blood pressure and if patient received any treatment due to this issue was not provided since it was an emergency situation.There was no allegation of patient injury reported.The patient outcome was stable.The device was available for evaluation.

• 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 ; 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: 17423135
• MDR Text Key: 320064643
• Report Number: 2015691-2023-14918
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2023

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 Operator: Health Professional
• Device Model Number: PX260
• Device Lot Number: 64687007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 63 KG