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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C. AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0007
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 06/05/2020
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

It was reported that an unspecified number of alaris pump module smartsite infusion sets experienced defective/damaged tubing. The following information was provided by the initial reporter: the cancer care center had three sets of iv tubing with holes, within two days. Two sets-ref 2420-007, are identified as lot is unknown, highly likely it is from the same lot as the other two sets. Was the suspected defect found before/during/after use on patient? (b)(6) 2020. Was there any adverse event reported regarding the patient or end-user for the incident reported? no adverse event.

 
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Brand NameAS LVP 20D 2SS CV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.
blvd. insurgentes 20351
tijuana, null 22244
MX 22244
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10216199
MDR Text Key198514768
Report Number9616066-2020-01979
Device Sequence Number1
Product Code FPA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number2420-0007
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
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: 06/30/2020 Patient Sequence Number: 1
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