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

Model Number HEMSGM10

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During use, co could not be measured due to unstable measured blood temperature.It is uncertain whether there was an error message.70cc2 cable was replaced by assuming its failure, but the symptom was not improved.A fault message of fault co blood temp out of range was observed after this replacement.Then the monitor was replaced from hem1 to vig2, bt and co could be measured.The amount of co was approximately 3l, and bt was 37 degrees.No patient injury reported.Per additional information from the sales rep, the unstable measured blood temperature initially mentioned means that the blood temperature value was displayed continuously, but the value rises and falls in a short period of time and could not maintain a constant temperature.The displayed value is unknown, and the expected value is around 36 degrees.No treatment or procedure was performed based on inaccurate values.No data available.Measurements are not considered to be influenced by patient condition.Patient demographic information requested but unavailable.Sw version of this device is 2.0.The swan ganz module was also swapped when the monitor was switched to hem to vig2.When hem1 and hemsgm10 were swapped to vig2, 70cc2 cable was not replaced and the second 70cc2 cable continued to be used.It is unknown if 70cc2 cable tests or normality checks were performed.

Manufacturer Narrative

Could not confirm reported event of no co measurements due to unstable measured blood temperature with fault message.During evaluation, any error messages were not observed.There was no physical damage that a part had to be replaced.The device passed all functional test.Further evaluation regarding related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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.

• Brand Name: PKG ASSY, SWAN GANZ
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17007965
• MDR Text Key: 316050905
• Report Number: 2015691-2023-13250
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2023

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 Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Device Lot Number: 13618294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1