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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES DR FINGER CUFF SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number CSCM
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2020
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is anticipated. However, the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation and device history results when received.
 
Event Description
It was reported that during use on patient of this clearsight fingercuff, the blood pressure (bp) provided by the fingercuff was significantly lower (47mmhg) than invasive arterial line (69mmhg), difference was around 20-30mmhg. Patient was left lateral decubitus (no initial clearsight bp in supine). First initiated on ring finger of left (down) hand, ipsilateral to radial arterial line. Physiocal
=
70 at this point. (see picture of red arterial line map
=
69 and pink clearsight map
=
47 on bedside monitor). Blood pressure on ev1000 matched the slaved pressure displayed on monitor, so pressure cable problem was ruled out(see pictures attached). The hrs zero and level was re-checked. It was changed to middle finger with no improvement in the pressure differences and physical was still good at 50-70. Finally, it was changed to middle finger of right (up) hand and clearsight blood pressure was closer (73 mmhg) with the clearsight map (83mmhg). It was around 10-15mmhg lower than arterial line and physical was 50-60. In both fingers the trends were concordant. Both patient¿s hands were warm and no apparent obstruction/restriction in the axilla. Tech support was called to assist with troubleshooting. No further suggestions and suspect a reduction in blood flow causing the discrepancy. There was no allegation of patient injury. The device was available for evaluation. As per follow up on (b)(6) 2020 it was clarified that patient was not treated according incorrect values. There was no error message displayed. Patient with no known medical conditions. Patient was lateral decubitus which could have caused a reduction in blood flow to the arm. It was also clarified the blood pressure from the clearsight was concordant with the arterial line, it trended in the same way and the discrepancy was consistent.
 
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Brand NameFINGER CUFF
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key9826030
MDR Text Key195908461
Report Number2015691-2020-10936
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeCA
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 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSCM
Device Catalogue NumberCSCM
Was Device Available for Evaluation? No
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 Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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