MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 VOLUMEVIEW CABLE; CATHETER, OXIMETER, FIBEROPTIC

Model Number EVVVTC1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for evaluation, but has not yet been received.Upon receipt and evaluation a supplemental mdr will be submitted with the evaluation results.The device history record reported no manufacturing non-conformances associated with this cable.

Event Description

It was reported that during use of a volumeview thermodilution cable, the temperature was "not stable and changed too fast", during patient monitoring.The issue was isolated to the cable through troubleshooting.When the nurse held the red side of the cable, good waveforms were noted.The monitor displayed "high fever" numbers that would change quickly, in the range of 20 degrees, when the red tip of the cable was touched.Replacement of the cable resolved the issue.It is unknown whether an alert or alarm was observed.No patient compromise was reported and no other system-related devices were identified as suspect.

Manufacturer Narrative

The initial report stated that the device was expected to be returned and evaluated.However, subsequent return requests revealed that per the customer¿s decision, the cable will not be sent for examination due to its assignment as a capital asset.Review of the complaint history was performed.This complaint is the only occurrence in a one-year period.The patient¿s body temperature by can be obtained by different means and compared to the temperature obtained from the catheter.When a failure such as this occurs, it is common clinical practice to trouble-shoot the issue.Clinicians using this product are highly trained to assess and mitigate any hazards and would recognize that the erratic changes in temperature would not reflect the condition of the patient.In this event, there was no note that a patient injury occurred because of the product problem.No patient demographics were able to be obtained.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.

• Brand Name: EV1000 VOLUMEVIEW CABLE
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7026898
• MDR Text Key: 92751583
• Report Number: 2015691-2017-03821
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: EVVVTC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68