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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 POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS POSITIVE PRESSURE CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP1000-C
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Hemolysis (1886)
Event Date 03/04/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. The customer complaint of resistance when drawing could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model mp1000-c because a lot number was not provided by the customer. 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 maxplus positive pressure connector had issues with hemolysis in the blood sample. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: "there is resistant when we draw back and a light whistling sound at times". "it was not a specific lot number. We felt it was those type of bd caps. Our hemolysis incidences seemed to increase when we started using them. When you draw back it actually whistles".
 
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Brand NameMAXPLUS POSITIVE PRESSURE CONNECTOR
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 Key11593783
MDR Text Key243175643
Report Number9616066-2021-50619
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072542
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 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMP1000-C
Device Catalogue NumberMP1000-C
Device Lot NumberUNKNOWN
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 Received03/04/2021
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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