MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CC CABLES 70CC2

Model Number 70CC2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The cable is expected to be returned and be evaluated.A supplemental report will be submitted to communicate the device history record review results as well as the investigation results.

Event Description

It was reported that during use of the 70 cc2 cable, the blood temperature (bt) was unstable from 48¿celsius to 10¿celsius.When the suspect cable was replaced, the issue was improved.No alarm or error message was observed.No patient injury was reported and there was no treatment given to patient due to this event.Patient demographics are unavailable.

Manufacturer Narrative

The 70cc2 cable was returned to be evaluated.The customer¿s report of blood temperature was unstable from 48 degrees c to 10 degrees c was confirmed.During testing, if the cable was moved or wiggled, the fault message ¿blood temp out of range (<31°c or >41°c)" was observed.The root cause was determined to be an intermittent disconnection of the cable.The device history record was reviewed with no related non-conformances found.With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically.Physiologic parameters are used to base clinical treatment decisions.In this event, the blood temperature reading was out of range, which would cause an incorrect co value to be displayed.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make treatment decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 a part of the monthly review.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: CC CABLES 70CC2
• Type of Device: CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7799405
• MDR Text Key: 118097476
• Report Number: 2015691-2018-03456
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2012
• Device Model Number: 70CC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1