MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUMEVIEW SYSTEM; PROBE, THERMODILUTION

Model Number VLVUNKNOWN

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation since it was from a clinical study made in 2019, so it was discarded.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.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.Clinical study made in 2019; therefore device discarded.

Event Description

The following information was obtained through an article published on critical care medicine journal in 2019: are peripherally inserted central catheters suitable for cardiac output assessment with transpulmonary thermodilution? during this study, when using volumeview systems, the cardiac index was significantly higher when measured with double-lumen 5f peripherally inserted central catheter than when measured with 4f peripherally inserted central catheter.Global end-diastolic index (gedi), extravascular lung water index (elwi), stroke volume index, (svi ), were also overestimated.The overestimation of cardiac output (co) observed was due to a significantly lower temperature detected by the femoral arterial thermistor (i.E., a higher temperature of injected bolus) when peripherally inserted central catheters (piccs ) were used for cold bolus injection when compared with centrally inserted central catheters (ciccs ) (0.27 degrees celsius vs 0.34 degrees celsius).The findings of this article were only for research purposes.Therefore no patient was treated according to the values provided.

Manufacturer Narrative

Updated: h6 (component code, type of investigation, investigation findings, investigation conclusions).H10 manufacturer narrative: based on further investigation by the engineers at the manufacturing site, the root cause could not be determined.As part of the manufacturing process, the units go through an electrical inspection.Additionally, as per review of instructions for use for volumeview sensor system, it indicates the customer to check the thermistor (blood temperature cable) using a compatible monitor.Edwards will continue to review and monitor all events.

• Brand Name: VOLUMEVIEW SYSTEM
• Type of Device: PROBE, THERMODILUTION
• 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: 16611819
• MDR Text Key: 312122271
• Report Number: 2015691-2023-11819
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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 Operator: Health Professional
• Device Model Number: VLVUNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1