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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® EXTENSION SET; FILTER, INFUSION LINE

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CAREFUSION ALARIS® EXTENSION SET; FILTER, INFUSION LINE Back to Search Results
Model Number 20029E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2016
Event Type  malfunction  
Manufacturer Narrative
The customer¿s report of a leak was not confirmed or replicated.Visual inspection revealed no damage anywhere on the extension set or any component.Functional testing and pressure testing resulted in no leaking.The root cause of the reported leak was not determined.
 
Event Description
The customer reported leaking from the filter of an iv set during a tpn infusion, dosage and rate not provided.The tubing was mated to a uvc (dual port, connected to the blue port), which was noted to have clotted off and was removed; picc was replaced.The tpn infusion was restarted using a syringe set mated directly to the blue port.There was no patient harm.
 
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Brand Name
ALARIS® EXTENSION SET
Type of Device
FILTER, INFUSION LINE
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 Key5939303
MDR Text Key54313275
Report Number9616066-2016-01148
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/12/2016
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 Number20029E
Device Catalogue Number20029E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2016
Initial Date FDA Received09/09/2016
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
Patient Sequence Number1
Treatment
8110,8015,30914,PICC,SPM TUBING, TD
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