MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CC CABLES 70CC2

Model Number 70CC2

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

Examination of the returned device was able to confirm the reported customer complaint.During evaluation, a fault message ¿blood temp out of range ( <31*c or >41* c )¿ was observed.This is thought to be due to customer abuse.The cable will need to be scrapped.A follow-up submissions will be sent to communicate the results of the device history records review and engineering evaluation results.It should be noted that the product evaluation of the monitor involved in this complaint showed no defect found.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 begin the troubleshooting process to discover the suspect device.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.No corrective or preventative actions are required at this time.

Event Description

It was reported that during use of the vig2 monitor, when the axillary temperature of the patient was 36°c, the blood temperature displayed on the vig2 was 38°c.After the suspect vig2 monitor and cables were replaced, the bt displayed was 36°c.At the time when the incorrect bt occurred, cco was also being measured along with the axillary temperature.No error message displayed was confirmed.There was no problems involved with any clinical treatment to patient.Patient demographics were unavailable at this time.There was no report of any patient compromise or injury due to this event.

Manufacturer Narrative

As per the findings in the engineering evaluation, no manufacturing non-conformance was found.A possible root cause of the damaged cable is customer mishandling of the cable.

Manufacturer Narrative

The device history record was reviewed; no related non-conformances were found.There were no previous related record of servicing noted.

• Brand Name: CC CABLES 70CC2
• Type of Device: CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7259794
• MDR Text Key: 100040713
• Report Number: 2015691-2018-00443
• Device Sequence Number: 1
• Product Code: ISN
• Combination Product (y/n): N
• PMA/PMN Number: K043103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Model Number: 70CC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2018
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1