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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT/MONITOR; HEM1 INSTRUMENT

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EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT/MONITOR; HEM1 INSTRUMENT Back to Search Results
Model Number HEM1
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 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.The udi information (b)(4).
 
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 hem1 instrument was received for product evaluation.The suspect hem1 was connected to a known good working sg module 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.There was no defect found.The sg module 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.Please refer to the following submission numbers for the sg module, hemosphere instrument and swan ganz catheter involved.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.
 
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Brand Name
HEMOSPHERE INSTRUMENT/MONITOR
Type of Device
HEM1 INSTRUMENT
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
MDR Report Key8750718
MDR Text Key149938629
Report Number2015691-2019-02404
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K163381
Number of Events Reported1
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 Received07/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/15/2023
Device Model NumberHEM1
Device Catalogue NumberHEM1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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