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

Model Number	PX260
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One disposable pressure transducer was received by our product evaluation laboratory for a full evaluation.As received, four unknown black particles were found.First particle was approximately 1x1 mm in size inside iv tubing at 215 cm from the drip chamber, the second was approximately 2x3 mm in size inside iv tubing at 550mm from dpt housing, third one was approximately 4x3 mm in size inside dpt housing and the fourth was approximately 3x3 mm in size inside drip chamber.In addition, three of the particles did not dislodge during 5 minutes of continuous flushing.However, the particle inside the dpt housing moved 2mm but remained inside the kit after 5 minutes of continuous flushing.No visible damage was observed from gel pad.No particulates were found on filter paper.The ir spectrum of unknown material showed similar absorption characteristics when comparing to silicone like material.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 or Problem Description
Initially, it was reported that during set-up this disposable pressure transducer, the snap-tab had saline leakage.The device was replaced by a new unit.Patient demographics were requested and unable to be obtained.The device was received for evaluation and unknown black particles were found inside the iv tubing.There was no allegation of patient injury.
Additional Manufacturer Narrative
Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Added information to section h6 (type of investigation) 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.Since further ir spectrum of the particles showed similar absorption characteristics when comparing to silicone-like material, an investigation was performed in the manufacturing lines to evaluate the possibility of this contamination being generated within the manufacturing process.Based on this, it is not confirmed that there is any machine or tool that could cause this nonconformance as silicone like material is not used on any part of the process.No potential cause for the condition reported was identified withing the manufacturing process.Nevertheless, a personnel acknowledgment was provided to the manufacturing personnel.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Common Device Name: 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: 19566600
• Report Number: 2015691-2024-04701
• Device Sequence Number: 17883302
• Product Code: DXO
• UDI-Device Identifier: 57460691950196
• UDI-Public: (01)57460691950196(17)250111(11)230112(10)64564471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2025
• Device Model Number: PX260
• Device Lot Number: 64564471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown