MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR VOLUME VIEW SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	VLV8R520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.No product is available to be returned for evaluation; it was discarded at the hospital.Nevertheless, one image was provided.Based on image review, the male luer of the manifold appeared completely broken near the temperature probe housing.
Event or Problem Description
As reported, during use in a patient in the cardiac icu (intensive care unit), when handling the manifold of this volume view sensor, it broke into two pieces (complaint (b)(4) / mfr 2015691-2025-00170).The device was replaced by a new one and, after two days of use, the manifold also broke into two pieces (complaint (b)(4).A third device was used.The blood loss was minimal.There was no allegation of patient injury.The devices were not available for evaluation since they were discarded; however, an image of the device involved in the complaint (b)(4) was available.
Additional Manufacturer Narrative
Corrected section d3 (manufacturer) and g1 (manufacturer site) added section a2 (patient age) / a3 (patient sex) / a4 (patient weight) / e1 (reporter establishment address) / h6 (component code, type of investigation, investigation findings, investigation conclusions) updated section g3 (date received by manufacturer), g6 (type of report) and h2 (type of follow-up).Evaluation results revealed that the reported event was confirmed based on image evaluation performed.Based on further engineering investigation, the root cause was determined to be inadequate product design since the current design of the manifold is not strong enough to withstand bending force applied in the field during product use, nor does the design provide a good gripping location to dissipate the excessive force.Corrective actions, including design change and a feasibility test, have been implemented in order to eliminate the cause of the non-conformity and prevent recurrence of this type of complaint.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.All events will continue to be reviewed and monitored.

• Brand Name: VOLUME VIEW SENSOR
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; carr. sanchez km 18.5; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; state rd indus pk 402 km 1.4; anasco, puerto rico, CA 00610 ; BR 00610 ; 9492503939
• MDR Report Key: 21111941
• Report Number: 2015691-2025-00171
• Device Sequence Number: 7679881
• Product Code: DRS
• UDI-Device Identifier: 00690103187014
• UDI-Public: (01)00690103187014(17)250720(11)230829(10)65237782
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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 Expiration Date: 07/20/2025
• Device Model Number: VLV8R520
• Device Lot Number: 65237782
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG