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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 CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV CKV 3 SS 20DP 20PK INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2426-0500
Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: one used primary set, model 2426-0500 lot 20033164, was received by the customer for investigation. An equashield luer lock adaptor and connector was also returned. Upon visual inspection of the iv set, it could be observed that the silicon tubing pumping segment was disconnected from the upper fitment. No other defects were observed. The customer's complaint that the tubing came apart with minimal force was verified. The expected retainer ring for this engagement was not received. A device history record review for model 2426-0500 lot number 20033164 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 11mar2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. Visual inspection under magnification was performed on the silicon pumping segment. A slight indentation of the retainer ring could be observed at the end of the tubing, indicating that the retainer ring was misaligned during the manufacturing process. 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: visual inspection under magnification was performed on the silicon pumping segment. A slight indentation of the retainer ring could be observed at the end of the tubing, indicating that the retainer ring was misaligned during the manufacturing process. Dimensional measurement confirmed the tubing to be within specification.
 
Event Description
It was reported that the gem v/nv ckv 3 ss 20dp 20pk experienced leakage and no label/missing label information. The following information was provided by the initial reporter: material no: 2426-0500 , batch no: unknown. This morning i was in the process of hanging avastin for a patient, and after inserting the primed tubing into the alaris pump, the tubing came apart when i exerted minimal force to the line. The place that the iv tubing came apart usually does not come apart, it is a blue connecting part directly above the bracket that sits in the top groove in the pump. I immediately clamped the line to avoid a spill, a very small amount of fluid leaked onto the floor, patient was not harmed, staff was not exposed to toxic medication.
 
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Brand NameGEM V/NV CKV 3 SS 20DP 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 Key10972706
MDR Text Key227622251
Report Number9616066-2020-20541
Device Sequence Number1
Product Code FPA
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
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2426-0500
Device Lot Number20033164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2020
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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