MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE ADVANCED MONITOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The hemosphere monitor involved in this event was not available for evaluation.Therefore, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.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 part of this monthly review.

Event Description

As reported, when customer used for the first time this hemosphere configuration, this hemosphere monitor transferred to ge bedside monitor a cvp of 0 mmhg when the hemosphere was on "pause mode" while patient hemodynamic parameter monitoring had stopped.Customer would like no numerical value being displayed at ge bedside monitor; however, when patient was put on cpb during an elective cabg x4 surgery, this hemosphere monitor (software v2.0), used with a flotrac sensor, was put on "pause mode" to eliminate the alarms caused by loss of pulsatile signal from flotrac when cpb was initiated.Then, the hemopshere monitor displayed amber light and a message indicating that the monitor was on "pause mode" and all values and waveform stopped being displayed.However, ge bedside monitor still displayed a 0 mmhg cvp value.Customer mentioned that the cvp is used to monitor pressures in the right atrium and when they are elevated, it signals that the cpb cannula may be mispositioned and require re-positioning by the cardiac surgeon.Physician advised that when the monitor displays zero for cvp, but cvp is not zero, this leads to maltreatment with potential complications.It was only recognized that the cvp waveform and 0 mmhg value was not coming from the patient when it did not change despite cpb weaning, indicating that there was a signal issue.Per further troubleshooting, the hemosphere was taken out of "pause mode" with resultant transfer of cvp waveform and correct values.There were no untoward surgical events, and short pump run of less than 1.5 hours.Patient developed postop atrial fibrillation requiring medical intervention of amiodarone.The patient had little to no risk of developing postop atrial fibrillation, and it is unknown at this time if this is permanent or transient atrial fibrillation.The only risk factors were age greater than 70 and female gender.Otherwise patient had normal ef, no chf, no pulmonary disease, and no history of arrhythmias.Patient woke up neurologically intact and no other harm was reported.The device was not available for evaluation.

Manufacturer Narrative

Further investigation was performed by the engineers.The customer was using the hemosphere platform with software version 2.0 while on cardiopulmonary bypass and standby mode (pause monitoring).In this version, while on standby mode the cvp value is displayed on the patient monitor as "0".This software version was not designed to provide pressure values during standby mode, so the design was instituted to display "0" as the cvp value.In this case, the user misinterpreted the "0" as a true pressure value instead of "no value" as intended by the software.Per the user the "0" value was reported as having the potential to cause mistreatment or lack of treatment.The user will be informed that software version 2.1.0.21 and future versions provide pressure values while in standby mode.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 part of this monthly review.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15392201
• MDR Text Key: 302712915
• Report Number: 2015691-2022-07787
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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: 76 YR
• Patient Sex: Female