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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
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
Customer reported ballooning of the pump segment while in use on a patient. No patient harm reported.
 
Manufacturer Narrative
Concomitant product: baxter 1000 ml 20 meq potassium chloride injection iv bag, lot # c994004, exp. Apr 2017; therapy date unk. The customer¿s report of ballooning was confirmed. Visual examination revealed that the silicone segment was slightly impaired near the upper fitment. Tactile examination confirmed that the subject area of the silicone segment had been weakened. Functional testing was performed. Slight bulging was noted during priming and a gravity infusion. No alarms were noted during a test pump infusion. Pressure testing was performed and the ballooning was replicated. The root cause of the balloon in the silicone segment could not be identified.
 
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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 Key5404353
MDR Text Key37308496
Report Number9616066-2016-00213
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2018
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number15126211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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