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 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to request product return and it has not arrived.Once it has arrived and the evaluation completed a supplemental report will be submitted with the findings.The device history record review was completed and all manufacturing inspections passed with no non conformances.The udi number is (b)(4).The mdr submission number of the sg module involved will be provided when available.

Event Description

It was reported that there were inaccurate values with the hemosphere instrument and swan ganz module.There were no fault messages reported.It is unknown the inaccurate numbers that displayed and what numbers were expected.The biomed from the facility received a note on the equipment that stated "wrong co numbers".He was not able to contact the user to obtain any additional information.He started up the system successfully and it checked out ok.The patient demographics are unknown.There was no inappropriate patient treatment reported.There was no patient harm or injury reported.

Manufacturer Narrative

Attempts were made to the facility to request product return.It did not arrive for evaluation.There are no evaluation findings available.The medwatch submission number for the sg module involved is 2015691-2021-04842.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12363032
• MDR Text Key: 268041539
• Report Number: 2015691-2021-04842
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)181227
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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 Expiration Date: 12/31/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SG MODULE