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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORP SMARTSITE EXTENSION SET
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CAREFUSION CORP SMARTSITE EXTENSION SET Back to Search Results
Model Number 20029E
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/18/2014
Event Type  malfunction  
Event Description
Customer reported that there was a crack in the set's filter, which resulted in tpn leaking onto the bed.The nurse caught the leak, stopped the tpn and ran d10w plain at the same rate as the tpn until the replacement tpn was delivered.No pt harm or medical intervention was reported.Although requested, no additional pt or event info was provided.
 
Manufacturer Narrative
(b)(4).Although requested, the set has not been received.A follow up report with investigation results will be submitted should the device be returned for evaluation.
 
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Brand Name
SMARTSITE EXTENSION SET
Type of Device
EXTENSION SET
Manufacturer (Section D)
CAREFUSION CORP
san diego CA
Manufacturer Contact
barbara ferris
10020 pacific mesa blvd
san diego, CA 92121
8586171163
MDR Report Key3904918
MDR Text Key4429655
Report Number9616066-2014-00495
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20029E
Device Catalogue Number20029E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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