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

Model Number VLV8R520

Device Problem Break (1069)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this volume view set, the manifold thermistor connector was found broken at the junction with the venous route central.The internal male part of the valve was stuck in the central venous line and was retrieved using forceps.There was no blood loss and the problem was solved changing the manifold thermistor.There was no allegation of patient injury.The device was received for evaluation.

Manufacturer Narrative

One volumeview was received by our product evaluation laboratory for a full examination.The report of manifold thermistor connector broken 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.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date) updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).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.Based on further engineering investigation, the root cause is related to inadequate product design since the current design of the manifold is not strong enough to withstand bending force applied in the field during product use, nor does the design provide a good gripping location to dissipate the excessive force.Corrective actions are being implemented.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 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; parque industrial de itabo; 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: 16782799
• MDR Text Key: 313713154
• Report Number: 2015691-2023-12449
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 64577605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2022
• 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: 54 YR
• Patient Sex: Male