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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS 0.2M CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 3SS 0.2M CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2432-0007
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that as lvp 20d 3ss 0. 2m cv tubing was loose and fluid was flowing out. The following information was provided by the initial reporter: material no: 2432-0007 batch no: 20075345. It was reported that there was an issue with the tpn tubing clamp. Verbatim: nch incident number: (b)(4). Can you describe the reported defect in detail? what happened? what was the cause? who was involved? bedside rn went to hang new tpn. Tubing used to spike new tpn bag. Immediately after spiking bag, fluid ran through tubing despite being clamped. Fluid was found to be flowing out mid-tubing, at the plastic clamp that is placed in the alaris pump channel. Can you provide the date(s) for the reported failure(s)? (b)(6) 2020. Was there any adverse event(s) as a result of the reported defect? if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc. ) and date. Yes initials: (b)(6) male, dob: (b)(6), prematurity. On (b)(6) 2020 patient did not get custom made tpn because of the tubing failure.
 
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Brand NameAS LVP 20D 3SS 0.2M CV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11089095
MDR Text Key238382009
Report Number9616066-2020-20668
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403232327
UDI-Public50885403232327
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2432-0007
Device Catalogue Number2432-0007
Device Lot Number20075345
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
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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