MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ MODULE

Model Number HEMSGM10

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for product evaluation; but has not yet arrived.When the findings are available a supplemental submission will be submitted.The device service history record review is pending.When the results are available a supplemental submission will submitted.The mdr submission number for the hem1 involved will be submitted in a supplemental submission.

Event Description

It was reported that while the hem1 instrument and swan ganz module were being used for patient monitoring that there were inaccurate continuous cardiac input values that displayed, per the clinician.There is no further information as to what the value numbers were that displayed nor what they were expected to be.There is limited information available.There was no inappropriate patient treatment reported.There was no patient harm or injury reported.

Manufacturer Narrative

The swan ganz module was not returned for evaluation after several attempts were made to request product return.However, the diagnostic log data was provided and reviewed.The data showed that the patient demographic information, specifically the weight, was entered incorrectly into the hem1 instrument.This would cause an incorrect corresponding cardiac index value to be displayed.Further review did not find any associated error messages indicating any hardware or software issues identified.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.There was no previous record of servicing for the device.The reported issue could not be confirmed by product evaluation as the product was not returned.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.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 could not be confirmed 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.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The mdr submission number for the hem1 instrument linked to this event is 2015691-2019-04024.The udi for the sg module is (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN GANZ MODULE
• Type of Device: SWAN GANZ MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9255984
• MDR Text Key: 196225044
• Report Number: 2015691-2019-04025
• 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
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: HEMSGM10
• Device Catalogue Number: HEMSGM10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1