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

Model Number VLVUNKNOWN

Device Problems Device Alarm System (1012); Incorrect Measurement (1383)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.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.Medwatch report number for the associated monitor (ev1000 platform): 2015-2018-03189.

Event Description

It was reported that during use of this volumeview set with an ev1000 system, the clinician noted a high evlw (extravascular lung water) value was displayed; however, there was no error message or alarm.The displayed value was 21 ml/kg instead of below 10 ml/kg, as expected per the patient¿s status.The patient was not treated based on the inaccurate value provided.There was no allegation of patient injury.Patient demographics were requested but not available.

Manufacturer Narrative

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

• Brand Name: VOLUMEVIEW CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7753873
• MDR Text Key: 116712095
• Report Number: 2015691-2018-03221
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLVUNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1