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 to be evaluated.A supplemental report will be submitted to communicate the dhr review results as well as the investigation results.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 cco 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.

Event Description

It was reported that during use of this 70 cc2 cable, the blood temperature (bt) was 38 degrees celsius but then it fluctuated to 17 degrees celsius after about one second.There was no error message observed.No patient injury was reported and no treatment was given to the patient.Patient demographics are unavailable.The suspect cable was replaced and the issue was resolved.

Manufacturer Narrative

Examination of the returned cable was able to confirm the reported issue.A fault message ¿blood temperature out of range (<31°c or >41°c)" was observed during the evaluation.It was confirmed the resistance value in the cable signal line was out of specification from wear and tear.The cable will be discarded.The confirmed serial number provided by the customer was not associated with a design history review on file.The design history review cannot be completed with the provided serial number.However, the product evaluation determined that the failure was due to wear and tear and therefore there would not be a manufacturing correlation between the device history record and the failure.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: 7798056
• MDR Text Key: 117998287
• Report Number: 2015691-2018-03441
• 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 Model Number: 70CC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1