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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number EVPMP
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2016
Event Type  malfunction  
Manufacturer Narrative
The device history record was reviewed and it supports that there were no non-conformances noted for any reason.The device is expected to be evaluated; however, at the time of this report, the device has not been returned.A supplemental report will be submitted to communicate the results of the complaint investigation results.The pc2k (pressure controller) will also be submitted and the mdr number will be referenced in the follow up for the pump unit.
 
Event Description
It was reported, that during the first day of use, of an ev1000 pump unit the clearsight measurements were 110-120/80-90 while the nibp (non-invasive blood pressure) were 150/65.On the second day of use the clearsight measurement were 93/56 compared to the nibp of 126/56.The hrs was replaced but the problem persisted.The patient was not treated based on the inaccurate clearsight values.No patient compromise was reported.Two devices were implicated in this event; one for the ev1000 pump unit and one for the ev1000 pressure controller.
 
Manufacturer Narrative
The device history record review was completed and all manufacturing inspections passed with no non-conformances.Examination of the returned device was unable to replicate the customer¿s complaint.Evaluation testing supports that the device performs as expected.It is unknown whether procedural processes or a specific circumstance played a role in the customer¿s experience, as the fault could not be replicated and no other issues were detected.No further actions are required at this time.Edwards will continue to review and monitor all events.If action is required, an appropriate investigation will be performed.The pressure controller (pc2k) was also submitted and the mdr number is 2015691-2016-02234.
 
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Brand Name
CLEARSIGHT PUMP UNIT
Type of Device
SYSTEM, 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
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key5796818
MDR Text Key49634823
Report Number2015691-2016-02233
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 foreign,health professional,o
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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