MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR VOLUME VIEW COMBO KIT; PROBE, THERMODILUTION

Model Number VLV8R520

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

As reported, during use of this this volumeview, the stopcock was found broken.There was no allegation of patient injury.The device was available for evaluation and the male luer on temperature probe side was found broken.

Manufacturer Narrative

The volume view involved in this case was sent to our product evaluation laboratory for a full evaluation.As received, the male luer on temperature probe side of volumeview manifold had been completely broken off.Broken mating part was not returned.Cross surface of broken luer was rough and uneven.No other visible damage was observed from returned unit.Customer report of manifold broken was 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.

Manufacturer Narrative

Further investigation was completed by the engineers in the manufacturing site, and it could be verified that 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 generated earlier to address this product failure.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.The device manufacturing data and expiration date were included in their respective fields h4 and d4.Also, the investigation codes (type of investigation, investigation findings and conclusions) were updated in their respective fields (h6) in order to better reflect the nature of the finding.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: VOLUME VIEW COMBO KIT
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15933016
• MDR Text Key: 306504452
• Report Number: 2015691-2022-09719
• 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
• Report Date: 01/19/2023

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 Expiration Date: 03/17/2023
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 63879238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 70 KG