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

Model Number	PX284AN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned but the evaluation has not yet been completed.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.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 a part of the monthly review.
Event or Problem Description
It was reported that the threads on syringes & threads on transducer are not lining up, causing syringe tip to break off in the transducer.When coming on shift, the customer noted that the syringe hooked up to stopcock on the cvp transducer was leaking even though it appeared connected.When inspecting further, the customer noted the tip broke off into the stop cock.This meant the transducer wasn't zeroed to air during the previous shift.When new transducer and syringe were hooked up (syringe from different lot but transducer from same lot), it immediately broke off again before syringe was even twisted on all the way.New transducer grabbed from new lot and syringe screwed on without any issues.Charge notified of equipment issue.No allegation of patient injury, device available for return.
Additional Manufacturer Narrative
One model px284an dpt with attached single iv set and a non-edwards 50ml b-d syringe was returned for evaluation.The customer report of threads on syringes & threads on transducer not lining up, causing syringe tip to break off was not able to be confirmed.Returned syringe could not be connected to dpt housing because tip of the syringe had been already completely broken and stuck inside the dpt vent port.Threads on syringe luer lock appeared damaged.No visible damage was observed from dpt vent port.Report of zeroing difficulty was not confirmed.Dpt sensor was able to be zeroed with broken syringe inside vent port.As no defect was found and the reported condition could not be confirmed, no product or process malfunction was identified.A root cause could not be established.As part of the manufacturing process, 100% of the units go through visual inspection, a leak test, an electrical test, and qa sampling.The lot number was not provided thus a device history record was not reviewed.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 the monthly review.

• Brand Name: TRUWAVE
• 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 IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21104901
• Report Number: 2015691-2025-00152
• Device Sequence Number: 20849868
• Product Code: DXO
• UDI-Device Identifier: 07460691950245
• UDI-Public: 07460691950245
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Model Number: PX284AN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/09/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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