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

Model Number	PXVJ0441
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
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 with the evaluation and device history results when received.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 a pressure tubing on a vamp was leaking and an error message was displayed on the monitor.While tubing was connected to patient umbilical art line, the error message of art line disconnected was displayed.Staff checked all connections and found vamp leakage on side of patient.Leakage was not located on the luer lock side.Per follow up with customer, uac fluid, a mixture of 50 ml sterile water with 2.5 meq sodium acetate and 25 units heparin, leaked from the tubing.It was connected to a non edwards pump.No patient injury reported.
Additional Manufacturer Narrative
The reported event of leaking was confirmed.As received, adhesive tape with note of leaking was noticed on zero stopcock and tubing female connector connection.Leakage was observed at the bond joint between pressure tubing female connector of vamp jr system during leak test.Red dye solution was manually injected into vamp system to trace leak path.Leakage was found occurring across tubing bond area.No other visible leakage or damage was noticed from the returned unit.Further evaluation regarding related quality issues is under investigation.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.
Additional Manufacturer Narrative
Engineering evaluation was completed and concluded that a product risk assessment escalation was needed.A device history record review was completed and documented that device met all specifications upon distribution.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.

• 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
• MDR Report Key: 15776036
• Report Number: 2015691-2022-09177
• Device Sequence Number: 4801183
• Product Code: DXO
• UDI-Device Identifier: 07460691954458
• UDI-Public: (01)07460691954458(17)231010(11)220429(10)64274903
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 10/10/2023
• Device Model Number: PXVJ0441
• Device Catalogue Number: PXVJ0441
• Device Lot Number: 64274903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 12/16/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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