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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 PRI TUBING
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Code Available (3191)
Event Type  Injury  
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 fluid leaked from a hole in the y-adapter on the iv set.Blood cultures were obtained from the patient's port.The port was deaccessed.There was no report of patient harm.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7801245
MDR Text Key117735921
Report Number9616066-2018-01353
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/21/2018
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
Treatment
8015, 8100, THERAPY DATE UNK
Patient Outcome(s) Required Intervention;
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