MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEM1; 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 07/30/2021

Event Type  malfunction  

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-comformances.

Event Description

It was reported that the hem1 co value seems to be cut in half.The rep switched fingers switched hrs and switched pc2ks but was still reading lower co ci sv svi.No other troubleshooting will help.There is no patient injury.There will be no product return but logs have been sent to be analyzed.Patient demographics were requested but unable to be obtained.There was no inappropriate patient treatment administered.

Manufacturer Narrative

A hemisphere monitor and clinical data logs were returned for this complaint.The monitor was run on a known working system for two hours and the values remained stable.No defect was identified during the investigation of the logs and the monitor during product evaluation.The system performed as designed.A pra was opened to address the risk of the allegations of low cardiac index and a capa was opened to facilitate any corrective actions.A potential root cause is a change in algorithm from the ev1000 system to the hemosphere system.It is unknown if user or procedural factors played a role in the allegation of inaccurate values.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 part of this monthly review.

Manufacturer Narrative

Logs were received and analyzed.Although the data appeared to correlate to the event description, the date did not.Additional attempts to clarify the issue are unable to be performed, as the initial reporter is no longer with ew.

• Brand Name: HEM1
• 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
• MDR Report Key: 12343322
• MDR Text Key: 267298321
• Report Number: 2015691-2021-04748
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)190301
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2022

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 Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 11/02/2021; 12/10/2021
• Supplement Dates FDA Received: 11/02/2021; 01/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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