MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT

Model Number HEM1

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

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

The product has been requested to be returned for evaluation but has not yet arrived.Once it has arrived and the evaluation has been completed the findings will be submitted in a supplemental submission.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The udi number is (b)(4).The other event that occurred at this facility will be reported in an mdr submission and when that submission number is available it will be sent in a supplement report.

Event Description

It was reported that the hemosphere monitor was displaying incorrect mean arterial pressure readings during patient monitoring.Initially, the reading was not showing up on the display screen.The doctor stated that both the cables had been exchanged and were appropriately connected to modules and ports on the hemosphere.He further verified that the serial ports were labeled correctly in the setup.The transducers were zeroed again and the hemosphere was rebooted.The patient data screen for the pressure reading began to populate, although the reading was not correct.The true reading for the patient was 67, while the hemosphere read 25.This reading fluctuated from around 45 to 57 before disappearing off the screen.There was no patient harm or injury.There was no inappropriate patient treatment reported.The patient demographics have been requested, but not provided.There was a previous event reported of inaccurate values at this time and will be reported under a separate submission.

Manufacturer Narrative

The product has been requested for return, but has not yet arrived.When it has been received and evaluated a supplemental report will be sent.The submission number for the other event linked with this event is 2015691-2022-03392.

Manufacturer Narrative

Several attempts were made to the facility to request product return and the unit was not received by edwards for evaluation.There is no product return and no product evaluation at this time.H3 other text : no product return.

Manufacturer Narrative

The unit was returned for evaluation.The hemosphere hem1 monitor was connected to a known good working sg module and hem oximetry cable for testing.The system verification test was performed, testing both module and smart cable ports.The co and sv02 values were within appropriate parameters.There were no error messages observed.Using the hemosphere instrument analog input cvp check procedure, the analog port 1 and analog port 2 both worked properly and displayed the appropriate cvp and map readings.There was no defect found.The reported issue was not confirmed.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13259142
• MDR Text Key: 285000597
• Report Number: 2015691-2022-03393
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190719
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CABLES, TRANSDUCERS