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

Model Number VLVFC520

Device Problem Break (1069)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in this case 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.H3 other text : device return ongoing, device not received yet.

Event Description

As reported, when setting up this volume view kit, while connecting the manifold in the cvc, the connector broke, not permitting the connection (medwatch reference# 19098).The same issue occurred with another kit during the same procedure, in the same position and situation (medwatch reference #19096).A third volume view kit was used and the issue was solved.There was no blood loss due to this incident.There was no allegation of patient injury.Patient demographics were requested but were not available.

Manufacturer Narrative

The device was not received for evaluation due to brazilian shipping requirements.Nevertheless, five pictures were reviewed by image evaluation.Pictures showed a dpt (disposable pressure transducer) kit with an attached manifold.The male luer on thermistor side of the manifold had been completely broken off.The broken male luer section was not visible in the photo.Image evaluation results revealed that the report of thermistor manifold broken was confirmed.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.Also, the investigation codes were updated in order to better reflect the nature of the finding.It was further informed that the model number of the device involved is vlvfc520 therefore it was updated in the applicable field in d4.Additionally, the manufacturing and expiration dates were added according to the device history record review.Patient gender was provided and field a3 has been updated to gender- male accordingly.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.H3 other text : device was not received for evaluation.Image evaluation was performed.

• Brand Name: VOLUMEVIEW COMBO KIT
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: samantha ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15238597
• MDR Text Key: 302719947
• Report Number: 2015691-2022-07338
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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: 06/16/2023
• Device Model Number: VLVFC520
• Device Lot Number: 63855412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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 Sex: Male