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

Model Number VLV8R520

Device Problem Break (1069)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in this complaint was not available for evaluation as it was discarded.Nevertheless, two pictures were provided for investigation and were examined.The report of manifold broken was confirmed.First picture showed the outer label of shipping box from reported model and lot number.Second picture showed a volumeview manifold.The male luer on thermistor side of the manifold had been completely broken off.An investigation has been initiated to consider any potential manufacturing 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 of this volumeview combo kit, the manifold broke.There was no allegation of patient injury.Patient demographics were requested, but not yet provided.The device was not available for evaluation as it was discarded.

Manufacturer Narrative

Additional information was provided.Patient demographics were not available due to hospital protection policy.Additionally, hospital address was provided.

Manufacturer Narrative

Upon further review, investigation codes were updated in order to better reflect the nature of the finding.

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.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.

• 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: 13117532
• MDR Text Key: 284974329
• Report Number: 2015691-2021-07113
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2022

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: 11/19/2022
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 63602702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 02/02/2022; 02/24/2022
• Supplement Dates FDA Received: 01/28/2022; 02/07/2022; 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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