MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ; CABLE CCO CATHETER INTERFACE

Model Number 70CC2

Device Problems Incorrect Measurement (1383); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.The reported issue was not confirmed by the evaluation.The cco was ran for over 10 minutes.The tests concluded with no functional faults found.There was no physical damage found in the visual inspection.The cable will be returned to the customer.The device history record was reviewed; no related non-conformances were found.There is no previous related record of servicing.No escalation is required.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this reported 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 a part of the monthly review.

Event Description

It was reported that, during use of this 70cc2 cable, the blood temperature was unstable.After the cable was replaced, the issue improved.There is no patient injury reported.The exact incident date is unknown; defaulting to the aware date.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ
• Type of Device: CABLE CCO CATHETER INTERFACE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9174928
• MDR Text Key: 195043832
• Report Number: 2015691-2019-03737
• Device Sequence Number: 1
• Product Code: DXG
• Combination Product (y/n): N
• PMA/PMN Number: K043103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: 70CC2
• Device Catalogue Number: 70CC2
• Device Lot Number: S11302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1