MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CCO; CATHETER, CONTINUOUS FLUSH

Model Number	139F75
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Defect in pa catheter.A copper wire extended from the connector for the co monitor cable.Staff were able to read pa and cvp via spacelab monitor.Staff was unable to get a continuous svr/co/ci due to connection issues.Fda safety report id # (b)(4).

• Brand Name: SWAN-GANZ CCO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 9596052
• Report Number: MW5092279
• Device Sequence Number: 16813631
• Product Code: KRA
• UDI-Device Identifier: 00690103000474
• UDI-Public: (01)00690103000474
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2020
• Device Model Number: 139F75
• Device Catalogue Number: 139F75
• Device Lot Number: 61321266
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 111