MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUMEVIEW; VOLUMEVIEW SYSTEM

Model Number VLV8R520

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Received one volumeview kit for evaluation.The reported event of manifold broken was confirmed.The male luer of swabbable luer site to connect cooled normal saline filled syringe of volumeview manifold had been completely broken off.Cross surfaces of broken luer were rough and uneven.No other visible damage was observed from returned manifold.No visible inconsistencies from rest of the returned unit.Further investigation is under evaluation.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use a catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using a catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Due to the positive pressure the heart and the ventilator places on the lines, blood will be pushed out into the system if a break were to occur.Therefore, a natural flow of gas into the patient body is possible, but unlikely.It is unknown if user or procedural factors contributed to the stated event.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 while using this volumeview, the thermistor manifold broke.It was during use on patient when injecting the ice water.There was no allegation of patient injury.Patient demographics are not available.

Manufacturer Narrative

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.

• Brand Name: VOLUMEVIEW
• Type of Device: VOLUMEVIEW SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11378237
• MDR Text Key: 245111811
• Report Number: 2015691-2021-01435
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/11/2021
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 62563363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1