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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ1000-07
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problems Air Embolism (1697); Hemorrhage, Cerebral (1889); Convulsion, Clonic (2222)
Event Date 12/02/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the maxzero needleless connector caused an air embolism and fluid leakage that led to a seizure and prolonged hospitalization. This complaint was created to capture the 2nd of 2 related incidents. The following information was provided by the initial reporter: "stroke/cvae050301 - air embolism, hospitalization or prolonged hospitalization e0109 - convulsion seizure a050401 - fluid leak, insufficient information, testing of actual/suspected device, device discarded, no findings available, results pending completion of investigation, no problem detected d15 - cause not established".
 
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Brand NameMAXZERO NEEDLELESS 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 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 Key11096462
MDR Text Key233559913
Report Number9616066-2020-20694
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
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 Received01/15/2021
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

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
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