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

Model Number	PXVP23X3AT3
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that viscous fluid was found in the reservoir of a truwave vamp during device set up.Hospital staff noticed that a ring in the syringe was left behind from the fluid when pushing the plunger up and back.No patient involvement.
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.
Additional Manufacturer Narrative
The device was not returned for evaluation.It was previously reported that the device was available for return, but it was discarded.An image evaluation was initiated for the customer provided photo.The photo showed a vamp plus reservoir.The reported event of ring of fluid inside the vamp reservoir was confirmed.A ring of what appeared to be clear material was visible inside the vamp plus reservoir.However, without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A supplemental report for the device history record will be forthcoming when the investigation is completed.Corrections to the h6 codes type of investigations were made.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.An image was provided by the customer, which confirmed the reported event.A potential cause could be related to the siliconizing process.Silicone oil, polydimethylsiloxane pdms, is used in the manufacturing process of the vamp plus as a lubricant to the inside walls of the body and plunger, cap interface.During the siliconizing process, the operator is required to insert the plunger into the body and carefully rotate it in and out to distribute the silicone throughout the body.In addition, visual inspection is required to ensure that there is no excess of silicone is observed inside the syringe.Corrections to the h6 codes investigation findings and investigation conclusions were made.

• 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: 18574576
• Report Number: 2015691-2024-00560
• Device Sequence Number: 15434576
• Product Code: DXO
• UDI-Device Identifier: 07460691950443
• UDI-Public: (01)07460691950443(17)250104(11)230105(10)64673585
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/18/2024

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
• Device Expiration Date: 01/04/2025
• Device Model Number: PXVP23X3AT3
• Device Lot Number: 64673585
• Was Device Available for Evaluation?: No
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 02/12/2024; 03/15/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/29/2024; 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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