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

Model Number VLV8R520

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2018

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 exist on the product, nor can a root cause or any potential contributing factors be identified.A device history record review has been initiated to assess that the device met all specifications upon distribution.Upon completion, a supplemental report will be sent with the investigation results.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.With any hemodynamic monitoring, temperature readings can change quickly and dramatically.A temperature reading that changes dramatically can be an indication to the user to begin the troubleshooting process before a cardiac output measurement is attempted.The patient¿s body temperature by can be obtained by different means and compared to the temperature obtained from the catheter.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort the attempt to obtain cardiac output.The catheter can be exchanged if desired.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 during use of a volume view set, the temperature values ¿jumped¿ between 0 to 43°c after completing the bolus injection.The clinician recognized the temperature values as abnormal compared to the patient condition and manual measurement obtained with a digital meter.The patient was not treated based on the temperature values provided and there was no allegation of patient injury.It was noted that all volume view parameters were being measured at the time of the issue; however, only the temperature values were reported as inaccurate.There were no error messages observed.The customer declined to provide patient demographics.

• Brand Name: VOLUME VIEW CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7339881
• MDR Text Key: 102454648
• Report Number: 2015691-2018-00900
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 60998517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No
• 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