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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 Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20065925, medical device expiration date: 2023-06-09, device manufacture date: 2020-06-08. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. (b)(4). Investigation summary: no product or photo was returned by the customer. The customer complaint of the tubing was found to be crooked in the pump segment which made it difficult to prime or irrigate the line could not be verified due to the product not being returned for failure investigation. A device history record review for model 11532269 lot number 20065925 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 09jun2020. 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.
 
Event Description
It was reported that the gem v/nv 20dp ckv 2ss 0. 2mf low sorbing experienced kinked tubing. The following information was provided by the initial reporter: material #: 11532269 , batch/ lot #: 20065925. A defect was found in the primary lines: bd alaris® pump infusion set 0. 2 micron filte, which are found to be crooked in the pump segment. This event was detected today, (b)(6) 2020 when preparing a very high cost monoclonal antibody, which made it difficult to do the "priming" or irrigation of the line.
 
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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 Key11092508
MDR Text Key234296242
Report Number9616066-2020-20684
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403232343
UDI-Public10885403232343
Combination Product (y/n)N
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,Followup
Report Date 01/04/2021
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 NumberSEE H10
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 Received01/04/2021
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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