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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0500
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problem Not Applicable (3189)
Event Date 09/10/2020
Event Type  malfunction  
Manufacturer Narrative
Multiple catalog & lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device catalog #: 2426-0500, medical device lot #: 20013117, medical device expiration date: 2023-01-13, device manufacture date: 2020-01-09. Medical device catalog #: unknown, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown. The initial reporter also notified the fda on 13 april, 2020. Medwatch report # mw5093988. Report source other: medwatch report. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that bd alaris pump infusion set tubing was damaged, leaked, blocked, and had large bubbles. This occurred on 3 occasions. The following information was provided by the initial reporter: event 1: material no: unknown, batch no: unknown. It was reported that tubing was "sliced" and leaking after tubing had been running for multiple hours. Event 2: material no: 2426-0500, batch no: 20013117. It was reported that new tubing noted to be "blocked" and large bubble created along the tubing that is in the arm of the iv pump. Event 3: material no: unknown, batch no: unknown. It was reported that iv pump tubing was leaking and a had a hole in the tubing with another tpn infusion. Event description per email states: "iv tubing in pump noted to be "sliced" and leaking after tubing had been running for multiple hours (no package info for this tubing) tubing changed then, new tubing noted to be "blocked", and large bubble created along tubing that is in the arm of the iv pump second regular iv tubing set (bubble) packaging info bd alaris pump infusion set, ref (b)(4), lot (10) 20013117, exp 01/13//2023 we recently had another issue with iv pump tubing leaking/ having a hole in the tubing with another tpn infusion no package info for this tubing fda safety report id # (b)(4)".
 
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Brand NameBD ALARIS PUMP INFUSION SET
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
8015652341
MDR Report Key10646209
MDR Text Key242381464
Report Number9616066-2020-20034
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0500
Device Catalogue NumberSEE H.10
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 Received10/14/2020
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: 10/07/2020 Patient Sequence Number: 1
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