MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 782HF75

Device Problem Incorrect Measurement (1383)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

It was reported that the cardiac output numbers are off.The readings cannot be trusted.The actual occurrence date is unknown.It was further indicated that numbers are done by fick method because the thermodilution numbers seem wrong.Patient not treated off these numbers.No patient complications reported.

Manufacturer Narrative

We received one 782hf75 catheter with an attached monoject 3ml syringe with 1.5 ml limited volume for examination.The thermistor was submerged in a 37.0c water bath and read 36.9c on the vigilance ii monitor.Thermistor temperature reading accuracy is +/- 0.3c per the vigilance manual.The thermistor was continuous with no open or intermittent conditions.The thermistor connector was opened and no visible inconsistencies were found.All through lumens were patent without any leakage or occlusion.The balloon inflated clear without leakage, but an eccentric balloon was observed.Eccentricity was measured and found to be out of specification.No visible damage and/or deterioration was seen on the balloon latex and balloon bonding site.No other visual damage, contamination, or other abnormalities were found on the catheter.The reported event was not confirmed for inaccurate cardiac output values therefore no actions will be taken.However an investigation has been opened for the confirmation of the eccentric balloon.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4835478
• MDR Text Key: 5907179
• Report Number: 2015691-2015-01353
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 782HF75
• Device Lot Number: 59878441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1