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

Model Number	PXVMP184
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that during use of the pxvmp184 vamp pressure monitoring set, the arterial line tubing was malfunctioning.The new set-up of the saline flush bag was infused over approximately 1-2 hours, 500ml of fluid was instilled.There was no additional treatment required to the patient to resolve the issue.There was no patient injury.The device is available for return.
Additional Manufacturer Narrative
Our product evaluation lab received one single dpt - vamp adult kit with attached empty 500ml iv bag.The customer report of infusion issue was confirmed.Leakage was detected from iv side to patient side of the dpt housing when flush device was close or not activated.Red dye was manually injected into dpt housing from iv side to trace the leak path.Leakage was found across bond area between flow restrictor and dpt housing.No other visible leakage or damage was observed from the kit.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been completed.This condition has been investigated by the applicable cross functional team and as part of the complaint investigation process, no specific root cause was identified.There are manufacturing controls to avoid potential causes related to the malfunction such as leak test, flow test, manufacturing continuous monitoring sampling, and qa sampling inspection.

• Brand Name: PRESSURE MONITORING KIT
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19747042
• Report Number: 2015691-2024-05364
• Device Sequence Number: 21051423
• Product Code: DXO
• UDI-Device Identifier: 07460691955103
• UDI-Public: (01)07460691955103(17)260314(11)240314(10)65595018
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2024

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: 03/14/2026
• Device Model Number: PXVMP184
• Device Lot Number: 65595018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 09/24/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/23/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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