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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MPX5301-C
Device Problems Material Separation (1562); Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter: address unavailable. Bd (b)(6) address used. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that maxplus pressure rated extension set with needleless connector and y-site had the components separate. The following information was provided by the initial reporter: "we are having issues with this extension set pulling apart while connected to the iv pump line. ".
 
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Brand NameMAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
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
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12694078
MDR Text Key278359574
Report Number9616066-2021-52304
Device Sequence Number1
Product Code FPA
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,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMPX5301-C
Device Catalogue NumberMPX5301-C
Device Lot Number21065785
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2021
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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