MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE MONITOR

Model Number HEM1

Device Problems Computer Software Problem (1112); Operating System Version or Upgrade Problem (2997)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

The unit has not been received for evaluation.Once received and any evaluation results that are available will be submitted in a supplemental report.The device service history record review is pending.When the results are available they will be submitted in a supplemental report.The other mdr submission numbers for the other 4 units involved will be submitted when available.

Event Description

It was reported that the hemosphere hem1 unit arrived at the facility with the incorrect software version.The facility had requested an overnight shipment of the units to use for surgery.When it arrived with the incorrect software it was not able to be used.The surgery was postponed.There were five hem1 units that arrived with the incorrect software version.There was no patient injury, but the surgery was postponed.

Manufacturer Narrative

The unit has not been received for evaluation.The evaluation results will be submitted in a separate follow up submission when available.The device history service record review was completed and all manufacturing inspections passed with no non-conformances.The other units involved have been reported with the following id submission numbers: 2015691-2022-04509, 2015691-2022-04510, 2015691-2022-04511, 2015691-2022-04512, and 2015691-2022-04513.

Manufacturer Narrative

The hemosphere instrument was returned for evaluation.The current software version was installed; however, it matched the original build software, shm 1.0.0.28, dbm 01.00.021.The panel screen was found to be damaged.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE MONITOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; one edwards way; irvine, CA 92614
• MDR Report Key: 13829357
• MDR Text Key: 289066382
• Report Number: 2015691-2022-04510
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)210228
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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