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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 11404930
Device Problems Split (2537); Material Deformation (2976)
Patient Problem No Information (3190)
Event Date 11/09/2015
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 that the tubing split while it was in use, location of the split unspecified.There was no patient harm, and no report of medical intervention.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, 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 Key5271948
MDR Text Key32861257
Report Number9616066-2015-01727
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K931173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 11/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11404930
Device Catalogue Number11404930
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/16/2015
Initial Date FDA Received12/07/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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