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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
Catalog Number MP1000 CHINA
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: an mp1000 china product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20076477. From the information provided by the customer it appears that the customer could not connect the maxplus to an unknown syringe or extension set; no further information was available to assist the investigation in this instance. The details of this feedback were forwarded to the manufacturing site for investigation. The root cause of the customer¿s experience could not be determined as the sample was not available for investigation. In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience. A review of the production records for lot 20076477 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mp1000 china product.
 
Event Description
It was reported that the maxplus positive pressure connector opened when connected to the syringe/micropump extension tube. The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, when the nurse in ward 19 used a needle-free connector for a patient, he discovered that the connector would automatically pop open when it was connected to a syringe or a micropump extension tube. Replaced it with a new needleless connector immediately and it can be used normally. ".
 
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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 Key12263974
MDR Text Key264780489
Report Number9616066-2021-51679
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072542
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
Report Date 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMP1000 CHINA
Device Lot Number20076477
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 Received07/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
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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