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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 Date 01/18/2016
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
The customer reported a pump segment bulge discovered during a routine tubing change for patient receiving potassium chloride, dosage and rate not specified. There was no leakage or patient harm. The tubing was changed and the patient's infusion continued without incident.
 
Manufacturer Narrative
Additional information provided from customer's medwatch. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
We received a copy of customer's medwatch report from fda which states "alaris iv tubing had an area of ballooning that was above the cartridge. It was discovered when the nurse unlatched the chamber door to the iv pump. Potassium chloride 40 meq in dextrose 5% in water,, @ a rate of 25ml/hr through tubing. ".
 
Manufacturer Narrative
 
Manufacturer Narrative
Concomitant products: (2)green swab caps; 100 ml hospira iv bag of potassium chloride 40 meq in 5% dextrose in water, lot 50-080-jt, expiration 1 feb 2017; therapy date (b)(6) 2016. The customer¿s report of ballooning in the silicone segment was confirmed. Visual inspection revealed that ballooning had occurred on the silicone segment next to the upper fitment. Tactile examination confirmed that the silicone segment had been weakened. Functional testing and pressure testing replicated the ballooning. The root cause of ballooning in the silicone segment could not be determined.
 
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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 Key5402964
MDR Text Key37271190
Report Number9616066-2016-00211
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 health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup,Followup
Report Date 01/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2016
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 Manufacturer02/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2016
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

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