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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN PRESSURE RATED SET W/ MAXPLUS INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN PRESSURE RATED SET W/ MAXPLUS INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MP5305-C
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
The initial reporter also notified the fda on (date) via medwatch # mw5096890. (b)(4). Investigation summary: one sample was returned for investigation. An investigation was performed. Sample was connected to a bd syringe and attempted to flush water through the set. Set was able to be primed. The customer complaint that the maxplus extension set would not flush after multiple attempts could not be replicated. The root cause could not be determined because the issue could not be replicated. A device history record review for model mp5305-c, lot number 20055016 was performed. The search showed that a total of (b)(4). There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. 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 7-in pressure rated set w/ maxplus was clogged/blocked/occluded. The following information was provided by the initial reporter: complaint 2 of 2: material #: mp5305-c , batch/ lot #: 20055016. Multiple attempts were made to flush through buff cap on end of extension set (with various from same lot number) and were unable. Had to change buff cap and able to flush and infuse ivf.
 
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Brand Name7-IN PRESSURE RATED SET W/ MAXPLUS
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 Key11092652
MDR Text Key225253814
Report Number9616066-2020-20685
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403236679
UDI-Public10885403236679
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
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 12/17/2020
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 Catalogue NumberMP5305-C
Device Lot Number20055016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2020
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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