MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774HF75

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A supplemental report will be forthcoming with the device history record results.

Event Description

It was reported that the catheter started out measuring properly and suddenly began measuring very high cardiac output values which were not related to the patient's clinical status.The monitor did not display any alarm.The clinician performed manual cold bolus's in order to evaluate cardiac output by thermodilution and was able to obtain values that were aligned with the patients status.The clinician did not take a picture and did not remember the values shown on the monitor.There was no more information available.There was no consequence for the patient as the user performed manual bolus.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION 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 00610
• 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: 4988008
• MDR Text Key: 23862314
• Report Number: 2015691-2015-01995
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2016
• Device Model Number: 774HF75
• Device Lot Number: 59890181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• 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