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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 11/20/2016
Event Type  malfunction  
Manufacturer Narrative
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
The customer reported a ballooned pump segment noted at the beginning of an unspecified 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.
 
Manufacturer Narrative
Conclusion code: field left blank- no available code for undetermined or unknown cause. The customer¿s report of bulge/balloon in the silicone segment was confirmed. The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components. A bulging silicone segment was found during visual inspection adjacent to the upper fitment. Functional testing confirmed bulging during priming and the gravity run. The root cause of the silicone segment bulge was not 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6207654
MDR Text Key63366839
Report Number9616066-2016-01912
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,Followup,Followup
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
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 Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
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: 12/27/2016 Patient Sequence Number: 1
Treatment
8015,8100,ADAPTOR, THERAPY DATE
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