MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; HEMOSPHERE ADVANCED MONITOR

Model Number	HEM1
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hemosphere was not transmitting the same patient parameter pressure numbers that the ge bedside monitor was receiving.The clinician stated the numbers did not correlate to the arterial blood pressure numbers displaying on the ge bedside monitor.This occurred for several minutes.The hemosphere read mid 80s systolic with the mean arterial pressure in the mid to low 60s.The ge monitor was showing the arterial waveform from clearsight in the low 100 to 119 systolic and the mean arterial pressure in the 70s.After the clinician re-zeroed, the bedside monitor arterial waveform did correlate with the hemosphere unit display for the systolic blood pressure in the mid 80s and the mean arterial pressure in the mid to low 60s.This occurred during patient use.There was no patient harm or injury.There was no inappropriate treatment administered.There is no product return as the user did not record the serial number of the suspect unit.It is unknown which unit is suspect.
Additional Manufacturer Narrative
The hemosphere will not be returned for evaluation as the suspect unit is not able to be identified.The device history record review cannot be completed as the serial number is unknown.An engineering evaluation has been initiated.Once the results are available, they will be submitted in a supplemental report.Additional device product codes, dqk computer, diagnostic, programmable.Qaq adjunctive predictive cardiovascular indicator, mud oximeter, tissue saturation.Dxn system, measurement, blood-pressure, non-invasive, dsb plethysmograph, impedance.Qms adjunctive open loop fluid therapy recommender, fll thermometer, electronic, clinical.
Additional Manufacturer Narrative
The unit was not received for product evaluation.An engineering evaluation was completed.Without the return of the product it is not possible to determine if some damage or defect existed that could have contributed to the event.There is not sufficient evidence to determine if this complaint was related to manufacturing, design, or labeling.It is not known if any procedural factors may have contributed to the event.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
• Common Device Name: HEMOSPHERE ADVANCED MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 20417058
• Report Number: 2015691-2024-07714
• Device Sequence Number: 12817502
• Product Code: DQE
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K163381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: HEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown