MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE; PRESSURE CABLE

Model Number	HEMPSC100
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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The device history record was reviewed and no related non conformances were found.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.Additional fda product codes include: dqe catheter, oximeter, fiber-optic dqk computer, diagnostic, programmable 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.
Event or Problem Description
It was reported that during use the hemosphere cable provided inaccurate values.The systolic blood pressure was reading 15 to 20 points difference from the hemosphere to the anesthesia monitor.Once the suspect cable was exchanged for a new one the readings displayed as expected.There was no treatment administered for the inaccurate values and no allegation of is no patient injury.
Additional Manufacturer Narrative
One hemosphere pressure cable was returned for evaluation.The outer most electrical contact of the front connector is bent or stuck down.The pressure cable connected to and communicated with a hemosphere monitor.The unit was zeroed, and a system verification test was ran three times.Mean arterial pressure values remained within parameters.Bending and moving the cable would not produce any errors.Customer report of inaccurate values was unable to be confirmed.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Therefore a root cause could not be established.

• Brand Name: HEMOSPHERE
• Common Device Name: PRESSURE CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 21764522
• Report Number: 2015691-2025-02557
• Device Sequence Number: 18323202
• Product Code: QAQ
• UDI-Device Identifier: 00690103199321
• UDI-Public: (01)00690103199321(11)231221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213682
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: HEMPSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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