MAUDE Adverse Event Report: ICU MEDICAL, INC. OPTIQ; SWANZ GANZ CATHETER

Lot Number 2967845

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

Prepping for emergent cabg, staff hooked swan ganz catheter per protocol for pre-insertion calibration.Device behaved as nothing hooked to it.Cables and cardiac monitor changed to no avail.Tried second catheter with same results.Both catheters from same batch number.Tried third catheter from different batch and no problems noted.All catheters from bad lot pulled from service.Bad catheters never touched a patient.

• Brand Name: OPTIQ
• Type of Device: SWANZ GANZ CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 4604014
• MDR Text Key: 19496998
• Report Number: MW5041409
• Device Sequence Number: 2
• Product Code: DYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Lot Number: 2967845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other