MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUMEVIEW COMBO KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	VLV8R520
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient of this volume view sensor, an unknown quantity of medication (methylene blue) leaked from the manifold.No action required due to medication loss.There was no allegation of patient injury.
Additional Manufacturer Narrative
It was further informed that the device was not available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.
Additional Manufacturer Narrative
Updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Added information 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.No product was returned for evaluation; it was discarded at the hospital.Nevertheless, images were provided for investigation.The report of leakage was confirmed, however without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.Images showed thermistor probe housing and swababble luer site of volumeview manifold.Leakage appeared to occur around temperature probe housing.There are manufacturing controls to avoid potential causes related to the reported malfunction.

• Brand Name: VOLUMEVIEW COMBO KIT
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 20167344
• Report Number: 2015691-2024-06911
• Device Sequence Number: 17907086
• Product Code: DRS
• UDI-Device Identifier: 00690103187014
• UDI-Public: (01)00690103187014(17)240804(11)230330(10)64935053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 08/04/2024
• Device Model Number: VLV8R520
• Device Lot Number: 64935053
• Was Device Available for Evaluation?: No
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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