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

Model Number T001645A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Electrolyte Imbalance (2196)

Event Date 09/17/2022

Event Type  malfunction  

Event Description

As reported, during use in patient of this pressure monitoring set, saline solution (ssi) was permanently flowing through the dpt housing without pulling the snap tab.About 3 bags of ssi 500cc went through in 24h before the issue was noticed.The problem was solved after changing the dpt.The only indicator was the excessive and unusual bag emptying with continuous drip.Consequently, the patient's fluid input and ionic balance have been disturbed, causing an hypokalaemia easily correctable by supplementation.Patient still in intensive care at this time, not related with this incident.Patient demographics were requested but not available.The device was available for evaluation.

Manufacturer Narrative

One pressure monitoring set was received by our product evaluation laboratory for a full analysis.The report of flow rate issue was confirmed.It was able to prime throughout the kit without any problem during priming test.No leakage was observed from the kit during leak test.However, flow rate testing indicated that the flow rate of 31 ml/hour, was out of specification.Specification was 3 +/- 1ml/hour per edwards instructions for use (ifu).Additionally, one piece of white material was observed between snap tab and dpt fluid path of fast flush flow.It appeared that there were gaps between the white particulate and the flush device housing which allow fluid to leak through, and the leakage created higher flow rate.The unknown white particulate, approximately 0.1" in size, was inside the dpt fluid path.The material stayed at the same location inside the dpt fluid path after 5 minutes of continuous flushing.The unknown white material was sent to chemistry for further analysis, and upon completion a supplemental report will be sent with analysis results.

Manufacturer Narrative

Based on further engineering investigation performed, it was determined that this issue is potentially related to the supplier manufacturing process; therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Additionally, device manufacturer and expiration dates were added.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

Based on further chemistry analysis, the ir spectrum of the unknown material found on the dpt fluid path had similar absorption characteristics when comparing to aluminum oxide like material.Aluminum oxide is used in the manufacturing process and is 'qualified'.Additionally, as per flushing test over 5 minutes the material stayed at the same location; therefore, risk for embolism is remote.

Manufacturer Narrative

Upon further engineering investigation review, a pra was already generated.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.

• 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: 15649257
• MDR Text Key: 302725382
• Report Number: 2015691-2022-08722
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: T001645A
• Device Catalogue Number: T001645A
• Device Lot Number: 64286656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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