MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN GANZ MODULE

Model Number HEMSGM10

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not been received yet.Upon return of the product, a supplemental report will be submitted with the evaluation findings.The device history record review is pending.When the findings are available the information will be submitted in a supplemental report.

Event Description

It was reported that there was a fluctuation of cardiac index values during patient monitoring with a hemosphere swan ganz module.The values fluctuated from 1.3 to 2.8.The patient was stable with a normal rhythm and with good pulses.An appropriate pa waveform was displayed.The suspect swan ganz module was removed and replaced with another swan ganz module and then the values were appropriate with no other changes.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information has not been provided.

Manufacturer Narrative

One swan ganz module was received for product evaluation.The suspect sg module was connected to a known good working hemosphere instrument (monitor) for testing and analysis.The system verification test was performed and left to run for over an hour.The cardiac output readings obtained were within appropriate parameters.The functional test was performed and the module passed the test without any issues noted.An external inspection was performed and there was no visible physical damage identified.There was no defect found.The reported event was not confirmed by evaluation.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether any user or procedural factors contributed in this 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 a part of the monthly review.

Manufacturer Narrative

The suspect swan ganz module was not returned by the facility for product evaluation after several attempts have been made.Edwards is unable to confirm or negate the customers experience without the return of the suspect device.If the product is received, a supplemental report will be submitted.The device service history record review was completed and all manufacturing inspections passed with no non-conformance's.There was no previous related record of servicing.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether any user or procedural factors contributed in this 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 a part of the monthly review.The udi is (b)(4).

Manufacturer Narrative

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

• Brand Name: HEMOSPHERE SWAN GANZ MODULE
• Type of Device: HEMOSPHERE SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8425963
• MDR Text Key: 139055637
• Report Number: 2015691-2019-00898
• 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: 02/22/2019

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: 11/28/2023
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 04/01/2019; 05/07/2019; 07/23/2020
• Supplement Dates FDA Received: 04/08/2019; 05/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1