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

Model Number	HEMCSM10
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-conformances.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text : awaiting device return.
Event or Problem Description
It was reported that the hemcsm10 blood pressure reading is inconsistent.The blood pressure readings were sporadic in that the systolic would become low then increase quickly without any interventions.It continued to happen so staff checked placement of the cuff made sure no lines were kinked and the hrs was re-zeroed.No damage was noted.This was during use.There was no inappropriate treatment administered and patient demographics were available.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.One hemcsm10 was received for product evaluation.The suspect hemcsm10 was connected to a known working hem1 hot mock-up system.The hemcsm10 caused no errors.It was also able to obtain normal blood pressure readings and waveform.The hemcsm10 was ran for half an hour without any errors.No damage was found.There was no defect.
Additional Manufacturer Narrative
Udi related data quality updates only the following are additional product codes for this device: dqe catheter, oximeter, fiber-optic, qaq adjunctive predictive cardiovascular indicator, mud oximeter, tissue saturation, dsb plethysmograph, impedance, qms adjunctive open loop fluid therapy recommender, fll thermometer, electronic, clinical, dxn system, measurement, blood-pressure, non-invasive.The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid): brand name: hemosphere.D2a.Common device name: computer, diagnostic, programmable.

• Brand Name: HEMOSPHERE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwdards way; irvine CA 92614
• Manufacturer Contact: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18314993
• Report Number: 2015691-2023-18324
• Device Sequence Number: 17838603
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203687
• 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,Followup
• Report Date (Section B): 07/18/2024

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 Expiration Date: 03/05/2026
• Device Model Number: HEMCSM10
• Device Lot Number: 16800882
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 07/09/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/13/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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