MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PKG ASSY HEM MONITOR; 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 11/16/2023

Event Type  malfunction  

Event Description

It was reported that there were inaccurate central venous pressure values that were imported from the hemosphere instrument, hem1, to the hospital bedside monitor, during patient use.The value on the hem1 was 2 to 3 mmhg and the bedside displayed 7mmhg.This occurred when both the port 1 and port 2 connectors were used on the hem1.The cable was unplugged from the bedside monitor and the cvp value became 0mmhg.There was no report of inappropriate patient treatment administered.The patient demographics were not provided.There was no patient harm or injury.

Manufacturer Narrative

The device has not been received for evaluation.Once it arrives and the product evaluation completed the evaluation findings will be submitted in a supplemental submission report.The device history record review is pending.Once the information has been received, it will be sent in the supplemental submission report.

Manufacturer Narrative

The reported issue was confirmed by evaluation when testing both port 1 and 2.There was a difference in the cvp values displayed on the hem1 and the values input.The failure was resolved by calibrating the analog pressure signal input using the functional test.There were no error messages observed.There was no physical damage found.The unit passed all functional testing.Based on the information received, re-calibration of the monitor was not performed on the occurrence date.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, it was confirmed that re-calibration of the monitor was not completed and that re-calibration during product evaluation fixed the issue.Per the ifu, perform calibration if the default values are incorrect.No escalation is required.No further investigation is required.The device history record review was completed and all manufacturing inspections passed with no non conformances.A supplemental mdr is being submitted due to product evaluation findings.Type of investigation, investigation findings, and investigation conclusions have been updated.

• Brand Name: PKG ASSY HEM MONITOR
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA ; JA
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA ; JA
• MDR Report Key: 18222483
• MDR Text Key: 329211795
• Report Number: 2015691-2023-17754
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model 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: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• 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