MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUME VIEW SET CUSTOM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number VLVJFC416CVT

Device Problem Break (1069)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of manifold was found broken was confirmed.Male luer was completely broken off from the manifold, and lock nut was not returned for evaluation.The broken male luer matched.Cross surfaces of the luer at the site of damage were rough and uneven.No other visible damages were observed on the manifold.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Event Description

It was reported that the manifold was broken during use.After the catheter insertion, the manifold broke while the patient was transferred.The customer commented that the issue might have been pulled during patient transfer, but it had never occurred before and therefore the manifold malfunction would also be suspected.The manifold was exchanged.No patient injury reported due to the event.Patient demographic information was requested but unavailable.

Manufacturer Narrative

The reported event of manifold was found broken was confirmed.Male luer was completely broken off from the manifold, and lock nut was not returned for evaluation.The broken male luer matched.Cross surfaces of the luer at the site of damage were rough and uneven.No other visible damages were observed on the manifold.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Event Description

It was reported that the manifold was broken during use.After the catheter insertion, the manifold broke while the patient was transferred.The customer commented that the issue might have been pulled during patient transfer, but it had never occurred before and therefore the manifold malfunction would also be suspected.The manifold was exchanged.No patient injury reported due to the event.Patient demographic information was requested but unavailable.

Manufacturer Narrative

An engineering evaluation was completed.A capa was initiated for this issue and a root cause was identified as inadequate product design.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 a part of the monthly review.

• Brand Name: VOLUME VIEW SET CUSTOM
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 13476987
• MDR Text Key: 285329407
• Report Number: 2015691-2022-03832
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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 Expiration Date: 05/15/2022
• Device Model Number: VLVJFC416CVT
• Device Lot Number: 63080067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2020
• 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