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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 11532269
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the gem v/nv 20dp ckv 2ss 0. 2mf low sorbing experienced leakage. The following information was provided by the initial reporter: complaint 2 of 2. I was informed of a hazardous medication spill from an infusion consisting of: etoposide, vincristine, daunorubicin. Medication infusion was being administered through bd primary filter tubing: ref ¿ 11532269 this was the second instance of the aforementioned combination hazardous medication for this patient leaking from the administration tubing near the filter site.
 
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Brand NameGEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
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 Key11092805
MDR Text Key250333940
Report Number9616066-2020-20687
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403232343
UDI-Public10885403232343
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 01/29/2021
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 Catalogue Number11532269
Device Lot NumberUNKNOWN
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 Received01/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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