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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUCLIP STAND, INFUSION

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EDWARDS LIFESCIENCES DR TRUCLIP STAND, INFUSION Back to Search Results
Model Number TRUCLIP
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
One truclip was returned for examination. The reported event of truclip "broke" was confirmed. The bottom inner clip was broken. The broken piece was not returned. One blue grip pad was detached and missing from the clip. Three blue grip pads were partially peeled, but weren't completely detached. No other visible defect or damage was observed from the unit. A supplemental report will be forthcoming with the device history results once received. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint. The truclip is designed to keep the pressure transducer at the phlebostatic axis for accurate pressure readings. In the event that the truclip is broken and does not remain stationary on the iv pole, it is possible to receive inaccurate pressure values. Pressure readings should correlate with the patient¿s clinical manifestations. It is unknown whether 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 this monthly review. No corrective or preventative actions are required at this time. This is 510k exempt as this is a class 1 device.
 
Event Description
It was reported that customer received inaccurate values (unknown the exact value) when the truclip that was attached to an iv infusion pole broke. It was noted the truclip damage was observed immediately, therefore, no treatment based on the inaccurate values was provided. No patient complications were reported. Patient demographics were unable to be obtained.
 
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Brand NameTRUCLIP
Type of DeviceSTAND, INFUSION
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
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key7501602
MDR Text Key108255184
Report Number2015691-2018-01774
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2020
Device Model NumberTRUCLIP
Device Lot Number60025591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2015
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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