MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMSGM10

Device Problems No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

Examination of the returned swan ganz module confirmed that while being connected to a data bridge interface test tool, measurements could not be obtained.A fault message ¿oximetry temperature¿ was displayed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically.Svo2 is one indicator of multiple hemodynamic parameters that are used to base clinical treatment decisions.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.Please see medwatch #2015691-2018-02757 for the hem1 monitor , and medwatch #2015691-2018-02796 for the oximetry cable involved in this event.

Event Description

It was reported during use of the swan ganz module, the hemosphere monitor stopped showing cardiac output (co) and cardiac index (ci).The next day, the monitor froze on svo2 measurements with no new values recorded.The clinician attempted to restart continuous cardiac output (cco), which was successful and accurate after rebooting the system.They were unable to perform the oximetry calibration.The monitor was exchanged for a vigilance ii, which worked appropriately with the same swan ganz catheter.There was no report of any patient injury or compromise, and no treatment was given to the patient due to this event.Patient demographics were unable to be obtained.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.Date of manufacture and expiration date corrected to 27-sep-2017and 26-sep-2022, respectively.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN GANZ MODULE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7842535
• MDR Text Key: 119502421
• Report Number: 2015691-2018-03661
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 07/23/2020
• Supplement Dates FDA Received: 09/21/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1