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

Model Number VLV8R520

Device Problem Break (1069)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during use in a patient with multiple head trauma, when performing the thermodilution, the manifold of this volume view broke.The device exchanged was made by the service.There was no allegation of patient injury.Device is available for evaluation.

Manufacturer Narrative

One manifold was received by our product evaluation laboratory for a full examination.The report of manifold broke was confirmed.The luer connection for central venous catheter of volumeview manifold had been completely broken off.Broken male luer was not returned.Cross surface of broken luer was rough and uneven.No other visible damage was observed from returned unit.The findings were aligned to the complaint photo however in complaint photo the male luer was visible inside the rotating nut and not returned for evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met, and inspections passed successfully.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.

Manufacturer Narrative

Based on further investigation in the capa, the root cause was related to product design.Corrective actions are in implementation phase to perform a design change and a feasibility test in order to eliminate the cause of the non-conformity and prevent recurrence of this condition.Additionally, a product risk assessment was performed.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.

Manufacturer Narrative

Upon further review, component and investigation codes were updated in order to better reflect the nature of the finding.Additionally, the expiration date, received date, common device name, device product code and 510k reference of the device involved were updated in their respective fields.

• Brand Name: VOLUMEVIEW SENSOR
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12710770
• MDR Text Key: 278797812
• Report Number: 2015691-2021-05991
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 62749332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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
• Patient Age: 28 YR
• Patient Sex: Male