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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES EV1000 PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EVPMP
Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer for testing and failed functional testing for verifying the pressure flow. At 150 normal liters per hour the difference pressure outlet measured 231 mmhg with a target of 0 and the limits at +/-10. It was found that one of the silicone hoses in the manifold bottom was pushed in. The test passed after reseating the silicone hose and pump to the manifold bottom. The front housing will be replaced. A device history record review was completed and documented that the device met all specifications upon distribution. An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Pressure readings should correlate with the patient¿s 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. In this event the pump unit failed the pressure output functional test and fell below the lower limits. No patient was involved. 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.
 
Event Description
It was reported that, at the hospital, the sales representative assembled the clearsight pump unit but when the device was tested, the fault message "pump-unit error" was observed. The sales representative reconnected the power cable and pump unit several times and turned the power on/off, but the issue did not improve. There was no patient injury reported. The device was returned to the manufacturer for testing and failed functional testing for verifying the pressure flow. At 150 normal liters per hour the difference pressure outlet measured 231mmhg with a target of 0 and the limits at +/-10.
 
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Brand NameEV1000 PUMP UNIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
jonathan diaz
one edwards way
irvine, CA 92614
9492503939
MDR Report Key10382589
MDR Text Key204066796
Report Number2015691-2020-12998
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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