MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR VOLUMEVIEW SYSTEMS; PROBE, THERMODILUTION

Model Number VLV8R520

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A device history record review was completed and documented that device met all specifications upon distribution.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion and the occurrence of complications is well described in the literature.In this case, the patient required a new stick to insert a new guidewire.It is unknown if user or procedural factors may have contributed to this 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 during use in patient with this volumeview set, the map (mean arterial pressure) value was very low.The value provided was less than 30 mmhg and the expected value according to the patient status was 75mmhg.Therefore, the system did not allow to injectate more saline cold bolus.The error message ¿check the arterial waveform¿ was displayed.The catheter placement in the artery was confirmed to be correct by a blood gas analysis and by b-ultrasond.The problem was solved after changing the femoral artery catheter for a new one.The new catheter was inserted using a new insertion site.There was no allegation of patient injury.The device was not available for evaluation since it was discarded at hospital.Patient demographics are not available.

• Brand Name: VOLUMEVIEW SYSTEMS
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 10512377
• MDR Text Key: 206376965
• Report Number: 2015691-2020-13491
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 62989953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2020
• 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