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

Model Number VLV8R520

Device Problem Break (1069)

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

Event Date 12/03/2021

Event Type  malfunction  

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.Nevertheless, one picture was reviewed.Customer report of manifold broken could not be confirmed from provided picture.Picture showed a closeup on a manifold with temperature probe attached to it.Customer circled the male luer of the t-connector (with swabbable luer sites) of volumeview manifold.It was unable to determine manifold damage from provided picture.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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.

Event Description

As reported, during use in patient with this volume view, the thermistor manifold was broken.There was not blood loss nor additional intervention required.The issue was solved replacing the catheter.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was not available for evaluation.

• Brand Name: VOLUMEVIEW
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13019712
• MDR Text Key: 282938514
• Report Number: 2015691-2021-06871
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• 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