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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Further clarification from the customer on (b)(6) 2017 determined that this event was initially reported in follow up 1 of report 9616066-2016-01548. The customer¿s report of a bulge/balloon in the silicone segment below the upper fitment was confirmed. No issues were observed during visual inspection but tactile examination found that the silicone segment tubing was weakened on its upper portion just below the upper fitment. Functional testing was performed; slight bulging was observed during priming and the gravity run. The set was then inserted into a pumping module and programmed to run at a rate of 125 ml/hr. The set ran for one hour with no alarms noted. Additional functional testing was performed by attaching a lab 10ml syringe filled with water to the distal smartsite to perform an iv push. An iv push was performed first by occluding the tubing above the injection port per (b)(4) iv push tip sheet, and then again by not occluding the tubing. No bulge/balloon was observed in either case when the device door was opened. The root cause of the silicone segment bulge was not identified.
 
Event Description
The customer reported a ballooned pump segment noted at the beginning of an infusion. The set was replaced and there was no patient harm. The customer has stated the description and event date provided was interpreted from other sources not provided to carefusion/bd and may not be completely accurate.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6298820
MDR Text Key66449804
Report Number9616066-2017-00159
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
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
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: 02/02/2017 Patient Sequence Number: 1
Treatment
(B)(4),(2)ORANGE SWAB CAPS, TD: UNK
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