MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE SWAN-GANZ MODULE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMSGM10

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The hemosphere swan ganz module was returned for evaluation.The reported issue was not confirmed from the evaluation.The hem1 monitor and oximetry cable were returned with the swan ganz module.All the components passed the safety test, functional test and run-in test.There were no defects found during testing.A device history record review was completed and documented that the device met all specifications upon distribution.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.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.It is unknown whether any user or procedural factors contributed to this reported 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 this monthly review.

Event Description

As reported, during use with this hemosphere swan ganz module, the cardiac output (co), end diastolic volume (edv), right ventricular ejection fraction (rvef) and systemic vascular resistance (svr) values were suspected to be inaccurate.The monitoring was stopped immediately once the issue was noted.The patient was not treated according to the incorrect values.The device was restarted and after restarting it took more than five minutes until the co and other data was displayed again.The values were still suspected to be incorrect.There were no error messages displayed.There was no further information available.There was no allegation of patient injury.The device was available for evaluation.

• Brand Name: HEMOSPHERE SWAN-GANZ MODULE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 10486279
• MDR Text Key: 206171969
• Report Number: 2015691-2020-13413
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2020

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: 07/24/2023
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• 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