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

Model Number HEM1

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

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

Event Date 05/01/2023

Event Type  malfunction  

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 with the evaluation and device history results when received.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.

Event Description

It was reported that blood temperature measurements were unstable, and co measurement stopped during use.The blood temperature values dropped to 2.6 celsius degree and then rose to 36.3 celsius degree in a short period of time.Additionally, error messages of light out of range and fault oximetry cable disconnected were displayed on the monitor.70cc cable passed the cable test.The issues were resolved by swapping the monitor and swan ganz module.The clinical log has been obtained by the sales rep.No patient injury was reported.Per additional information from sales rep, the values displayed on the monitor were not stable and fluctuated in a short period of time.The expected values were around 36 celsius degree.No additional treatment and procedures were performed based on the inaccurate values.The values did not reflect the clinical condition of the patient.No patient demographic information was obtained.The procedure during the case and if staff used other medical devices is unknown.Device malfunction of the disposable products was ruled out as the issue was resolved by swapping the monitor and sgm.

Manufacturer Narrative

A product evaluation was completed.The reported complaint could not be confirmed.4 rubber feet were missing, so attached them.Functional test was performed.During evaluation, any error messages were not observed.The device passed all functional test.Dom is 24 jun 2022.An engineering evaluation was also completed.Updates to the h6 codes are as follows investigation findings was changed to no device problem found and investigation conclusions was changed to no problem detected.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.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16965863
• MDR Text Key: 315595538
• Report Number: 2015691-2023-13075
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2023

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
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Device Lot Number: 13842229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 07/19/2023
• Supplement Dates FDA Received: 06/28/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1