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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 117-IN 20PK INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 117-IN 20PK INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0500
Device Problem Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: no product or photo was returned by the customer. The customer complaint of dripping from the tubing between the safety clamp and roller clamp could not be verified due to the product not being returned for failure investigation. A device history record review for model 2420-0500, lot number 20063012 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 12jun2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Due to no sample being received, an investigation could not be performed and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
Event Description
It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced leakage. The following information was provided by the initial reporter: material no: 2420-0500, batch no: 20063012. Date of incident (yyyy-mm-dd): 2020 (b)(6). Chemotherapy noted to be dripping from the tubing between the safety clamp and roller clamp at the point of the collar. Chemo spill protocol followed. Risk of exposure to staff. Patient missed part of treatment. Who was affected? patient.
 
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Brand NameGEM V/NV 20DP CKV 2SS 117-IN 20PK
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 Key11233986
MDR Text Key229389785
Report Number9616066-2021-50104
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2420-0500
Device Lot Number20063012
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2020
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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