MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE; SG MODULE

Model Number HEMSGM10

Device Problems Incorrect Measurement (1383); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned for evaluation.Attempts for product return will be made to the facility.Upon return of the unit and after the evaluation findings are available a supplemental report will be submitted with the findings.The design history record review is pending.A supplemental report will be submitted with the findings.The mdr submission numbers for all components involved will be provided in a supplemental report.

Event Description

It was reported that the swan ganz module, hemosphere instrument monitor and swan ganz catheter were being used during patient monitoring.There were fluctuating ci values that displayed.They were from 4.0 to 1.4 without any change in the patient condition.The edwards clinical field specialist performed troubleshooting with the components, but could not determine the source of the issue.The physician stated to the edwards cfs that this issue had happened previously.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information has been requested.

Manufacturer Narrative

One swan ganz module was received for product evaluation.The suspect sg module was connected to a known good working hemosphere instrument and oximetry cable for testing and analysis.The system verification test was performed.The cardiac output values and sv02 values displayed were within appropriate parameters.The cardiac index value remained consistent for thirty minutes during testing.A visual inspection was performed on the product and there was no physical damage identified.The sg module internal board was upgraded from a rev 5 to rev 6.There was no defect found.The hem1 instrument involved was received for product evaluation.There was no defect found.The sg catheter involved was not received for evaluation.It could not be determined if it was a contributor to the reported issue.The reported event was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.It is unknown if user or procedural factors contributed to the stated event.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 the monthly review.The device history record review was completed and all manufacturing inspections passed with no non-conformances.The record of servicing has been reviewed and there is no previous related record.

Manufacturer Narrative

The product has not arrived for evaluation.Once the product has been returned and evaluated a supplemental submission will be sent with the evaluation findings.The device service history record review is pending.Once the results are available a supplemental report will be sent with the findings.The udi number is (b)(4).Swan ganz module 2015691-2019-02403 swan ganz module 2015691-2019-02405 hemosphere instrument 2015691-2019-02404 hemosphere instrument 2015691-2019-02406 swan ganz catheter 2015691-2019-02440 swan ganz catheter 2015691-2019-02441.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: HEMOSPHERE SWAN GANZ MODULE
• Type of Device: SG MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8750727
• MDR Text Key: 150007704
• Report Number: 2015691-2019-02405
• Device Sequence Number: 1
• Product Code: DQK
• 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,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1