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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 Insufficient Information (4580)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter also notified the fda on (date) via medwatch # mw5096907. Investigation summary: no product or photo was returned by the customer. The customer complaint that the maxplus extension set would not flush after multiple attempts could not be verified due to the product not being returned for failure investigation. 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. 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 7-in pressure rated set w/ maxplus was clogged/blocked/occluded. The following information was provided by the initial reporter: material #: mp5305-c batch/ lot #: 20055016 maxplus extension set, multiple attempts were made to flush through buff cap on end of extension set (with various from same lot number) and were unable.
 
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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 Key11092679
MDR Text Key225030607
Report Number9616066-2020-20686
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? No
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? Device Not Returned to Manufacturer
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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