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 08/11/2021

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 not completed but will be provided after it has been finished.

Event Description

It was reported that the hem1 generated inaccurate numbers.The clinicians stated the ci was 2.1 in the or and when the patient was moved to monitor in the icu the ci was 1.3.The placement of the swan was confirmed.The cable test passed and was reattached.The values remained the same.They changed cables and the sg module but the problem persisted through all troubleshooting measures.There is no patient injury.Patient demographics were requested but unavailable.

Manufacturer Narrative

The hem1 was not returned by the customer.However, logs were provided.Based on the logs provided, the alleged inaccurate hemodynamic parameters could not be confirmed.There was no product malfunction identified.H3 other text: logs provided.

• 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 ; 9492500294
• MDR Report Key: 12439410
• MDR Text Key: 270312633
• Report Number: 2015691-2021-05062
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)210327
• 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
• Report Date: 11/15/2021

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 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
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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