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

Model Number VLV8R520

Device Problems Difficult to Insert (1316); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

One volumeview sensor, (1) dpt sensor and (2) pressure lines and (2) iv lines were returned for examination.The reported event of " thermodilution values were not obtained" could not be confirmed since the manifold and femoral artery catheter were not returned.However, both the dpt and volumeview sensors of volumeview combo kit zeroed and sensed pressure accurately on an ev1000 and pressure monitors.No error message was noticed from the monitors.Electrical testing showed that both input and output impedances were within specifications.Zero-offset of the sensors also met specification.No leakage or occlusion was detected from the returned kit during pressure test.No visible damage was observed from the kit.A review of the manufacturing records indicated that the product met specifications upon release.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.The volumeview set, when used in conjunction with the edwards ev1000 clinical platform, is designed for measurement of continuous and intermittent transpulmonary thermodilution (tptd) parameters.The volumeview set enables measurement of intermittent cardiac output (ico) and a range of volumetric parameters including extravascular lung water (evlw) and global end-diastolic volume (gedv).Per the cautions section of the ifu: ¿erroneous measurements can be caused by an incorrect catheter position or by electromagnetic disturbance (such as an electric blanket)¿repeat the measurement if the results are implausible.¿ volumeview sensor maintenance is required to avoid catheter occlusion and/or avoid inaccurate pressure measurement or cardiac output calculations.Proper volumeview sensor maintenance includes assuring: proper leveling of sensor, pressure bag inflated to 300 mmhg, adequate flush volume, assessment of waveform quality, and periodic assessment of frequency response.The volumeview venous injectate kit setup section of the ifu notes that ¿attaching the volumeview venous injectate kit to the central venous catheter is required to obtain volumeview parameters.Additionally, an illustration of the product is provided with a note indicating that all components ¿are required for the system to function properly.¿ per the thermodilution measurement section of the ifu, step 4 instructs to ¿select cooled normal saline filled luer lock syringe.Caution: warm injectate may result in inaccurate measurements.Assure timely usage of cooled normal saline filled syringes.¿ it is unknown whether 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 part of this monthly review.

Event Description

It was reported that while connecting to the ev1000 monitor using the volumeview kit, the thermodilution values were not able to be obtained.The volumeview kit was changed for another one in order to solve the issue.Further follow up with the customer indicated that the procedure was started from the beginning by removing everything and inserting the needle again.There was no patient injury.Patient demographics unable to be obtained.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: VOLUMEVIEW SET
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 9850016
• MDR Text Key: 195114372
• Report Number: 2015691-2020-11014
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 62452520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1