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

Model Number 139F75

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 01/08/2020

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 9596052
• MDR Text Key: 175829326
• Report Number: MW5092279
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00690103000474
• UDI-Public: (01)00690103000474
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 111