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

Model Number HEMSGM10

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The hemosphere swan-ganz module was returned for evaluation.The reported issue was not confirmed.A functional test was performed and the unit passed all tests.The running test was ran with a simulator for over 80 hours.There were no error messages observed.There was no physical damage that a part had to be replaced.The device history record was reviewed; no related non-conformances were found.There was no previous related record of servicing.With any hemodynamic monitoring, patient parameters can change quickly and dramatically.Cardiac output readings should correlate with the patients clinical manifestations.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 event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the.

Event Description

It was reported that during a procedure using this swan-ganz module, the cardiac output (co) value indicated around twenty times more during use of a v-a ecmo.It lasted for more than ten minutes, then returned to normal, but then the issue occurred again.The issue did not improve when replacing the monitor.There were no error messages observed and any information regarding the waveform was unknown.The patient demographics were requested and received.The hem1 and 70cc2 involved in this event were returned for evaluation as well.There was no patient injury reported.

• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12071408
• MDR Text Key: 259251072
• Report Number: 2015691-2021-03788
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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
• Patient Age: 42 YR
• Patient Weight: 55