MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; MONITOR

Model Number HEM1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned, however the evaluation has not yet been completed.A follow-up communication will be submitted upon receipt of the investigation and results of the review of the device history record.

Event Description

The cvp value displayed on hem1 monitor was 1 mmhg, whereas 7 mmhg displayed on the nihon kohden patient monitor during use.Note that the analog input calibration was not performed.No patient compromise and no inappropriate treatment administered and no additional system related devices were reported.

Manufacturer Narrative

Per clinician review this event is no longer deemed reportable no death or serious injury; potential for death or serious injury is remote.A complaint with no injury or mistreatment and no product malfunction would be considered use error and a non-reportable event.In this case the user did not perform the analog calibration as noted in the operators manual, which states the accuracy of continuous svr while monitoring with the hemosphere swan-ganz module depends upon the quality and accuracy of the map and cvp data transmitted from the external monitors.Since map and cvp analog signal quality from the external monitor cannot be validated by the hemosphere advanced monitor, actual values and the values (including all derived parameters) displayed by the hemosphere advanced monitor may not be consistent.The accuracy of continuous svr measurement, therefore, cannot be guaranteed.To aid in determining the quality of the analog signals, regularly compare the map and cvp values displayed on the external monitor to the values displayed on the physio relationship screen of the hemosphere advanced monitor.Refer to the external input device operators manual for detailed information regarding accuracy, calibration and other variables which may impact the analog output signal from the external monitor.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12391496
• MDR Text Key: 268921513
• Report Number: 2015691-2021-04926
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)200928
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1