MAUDE Adverse Event Report: ICU MEDICAL, INC. THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Lot Number 42-478-SL

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Patient had swan ganz catheter inserted.The next day at 2000, rn attempted to get cardiac output and hemodynamic numbers.Rn unable to get numbers, monitor reading "no tblood transducer connected".Attempted to fix problem, exchanged monitoring cables and same problem continued.Manufacturer response for thermodilution catheter, (brand not provided) (per site reporter).
=
no response received to date.

• Brand Name: THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 4199742
• MDR Text Key: 4964601
• Report Number: 4199742
• Device Sequence Number: 1
• Product Code: DYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 42-478-SL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2014
• Patient Sequence Number: 1
• Treatment: NOT AWARE
• Patient Age: 73 YR