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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10014914
Device Problem Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20076740. Medical device expiration date: na. Device manufacture date: 2020-07-16. Medical device lot #: 20076646. Medical device expiration date: na. Device manufacture date: 2020-07-14. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 1 as syr psd microbore from lot 20076740 and 1 device from lot 20076646 had issues with cracks. As a result, the patients did not receive their full dose of medication. This complaint was created to capture the 3rd of 3 related incidents. The following information was provided by the initial reporter: "we had two more instances over the weekend of tubing set 10014914 cracking in the same location. This continues to impact our patient care and is putting our patients at risk both for infection and air embolism, not to mention, when these sets crack and leak, they are not receiving their medications. We had two lot numbers stocked in our unit: (10)20076740 and (10)20076646. " "syringes were attached directly to the female luer. Two were intermittent medication lines, which are changed out every 24 hours. Cefepime, lasix (both in bd syringes), and pre-filled 3 ml saline flushes (monoject) are the only medications/fluids that went through those lines before the leaking was detected. The report from last week involved a continuous milrinone infusion. We do not use any alcohol or chemicals on the female luers prior to connecting the syringes, and we do not use hemostats on these pieces. The syringes are not being over tightened. This exact issue has been occurring with this and other bd products that utilize this female luer connector since i assumed this role in 2011. Several rcas conducted in 2016 indicated the issue was ¿supplier-related¿ but provided no other details (pr 91041; pr 120977). All other rcas confirmed cracks and leaking, but failed to identify a root cause, other than suggesting user error. ".
 
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Brand NameAS SYR PSD MICROBORE
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 Key10909597
MDR Text Key220472776
Report Number9616066-2020-20461
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K811885
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 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10014914
Device Catalogue Number10014914
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
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: 11/26/2020 Patient Sequence Number: 1
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