MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OXIMETRY OPTICAL MODULE 2; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMOXSC100

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

It was reported that while using this entire hemosphere system, which included the hem1, hemsgm10, hemoxsc100, 70cc2, and swan-ganz catheter, no hemodynamic parameters (including co and svo2) were indicated on the monitor when the patient was transferred from the catheterization laboratory to the hcu and connected to the monitor.The nurse was working on it for an hour, but the problem was not solved.The medical engineer inspected and confirmed that an error message "not calibrated" was displayed on the monitor.Calibration of the svo2 was performed and the cable test was carried out for a disconnection check.After passing the cable test, the 70cc2 cable and hemoxsc cable were reconnected and the co and svo2 values were shown on the monitor.These values, however, were lower than expected and did not fluctuate (the indicated co value: 1-2, svo2: unknown).The target indicators for co and svo2 turned yellow and red.The indicated signal quality index (sqi) level was 1 - normal (hemosphere version 1.1).There was no error message observed at this time.Echocardiography suggested that the values were not affected by the patients condition, therefore, the patient was not treated based on the incorrect values.Since the values shown on the monitor remained low for a while, recalibration and reconnection of the cables were performed.Then the indicated co values became 4-5, which were considered as reasonable values through echocardiography.The svo2 value also appeared to be normal, although the exact value was unknown.These values fluctuated properly, and the measurement was continued.It was confirmed that in-vivo calibration was performed in this case.Measurement data of blood gas analysis was unknown.The indicated value after in vivo calibration was unknown.The percutaneous coronary intervention (pci) was performed, and the patient was on intra-aortic balloon pumping (iabp).When transferring from the catheterization laboratory, the iabp was removed from the patient.The patient was not under hypothermia therapy.Lower limb compression device (covidien kendall scd) was used in this case.The customer commented that they usually used compression device during measurement, but this kind of issue had not occurred before, so they requested to evaluate the devices.There was no patient injury reported.Patient demographics were received.The software logs were requested for evaluation.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results, as well as the device history record review.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.

Manufacturer Narrative

The hemosphere oximetry cable was returned for evaluation.The reported issue of low co values was not confirmed.Functional test was performed.During evaluation, no error messages were observed.There was no physical damage that a part had to be replaced.The device passed all functional tests.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: OXIMETRY OPTICAL MODULE 2
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12866534
• MDR Text Key: 283511179
• Report Number: 2015691-2021-06490
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Device Lot Number: 16603015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG