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

Model Number VLV8R520

Device Problem Break (1069)

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

Event Date 10/31/2021

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 patient of this volumeview combo kit, the thermistor manifold was found broken.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The device was received for a full product evaluation.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.Evaluation results revealed that the report of thermistor manifold broken was confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.On the other hand, 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.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, investigation findings and conclusions codes were updated in order to better reflect the nature of the finding.Additionally, the brand name, common device name, device product code and 510k reference of the device involved were updated in their respective fields.

• Brand Name: VOLUMEVIEW SYSTEM
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12860305
• MDR Text Key: 284970872
• Report Number: 2015691-2021-06460
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

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 Expiration Date: 01/26/2023
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 63687427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 02/21/2022
• Supplement Dates FDA Received: 12/27/2021; 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 51 KG