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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORP.ALARIS PUMP MODULE IV ADMINISTRATION SET

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CAREFUSION CORP. ALARIS PUMP MODULE IV ADMINISTRATION SET   Back to Search Results
Model Number 2420-0500
Event Date 01/25/2011
Event Type  Malfunction  
Event Description

Customer reported via e-mail the following event: while infusing iv iron into the venous port of the dialysis system, they noticed that there appeared to be iron spilled on the bottom of the dialysis machine under the venous port. Although, the iv tubing was securely inserted and the luer lock was secure, it continued to leak. The infusion was discontinued. No patient harm or medical intervention was reported.

 
Manufacturer Narrative

Manufacturer's report date: 03/23/2011. (b)(4). The customer discarded the used set. The cause of the leak could not be determined. If the administration set was being used with the alaris pump, connection to a dialysis system would be considered off label use.

 
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Brand NameALARIS PUMP MODULE IV ADMINISTRATION SET
Manufacturer (Section F)
CAREFUSION CORP.
san diego CA
Manufacturer (Section D)
CAREFUSION CORP.
san diego CA
Manufacturer Contact
jennifer terrell
10020 pacific mesa blvd.
san diego , CA 92121
(858) 617 -1472
Device Event Key2082224
MDR Report Key2039577
Event Key1936538
Report Number9616066-2011-00084
Device Sequence Number1
Product CodeFPA
Report Source Manufacturer
Source Type Foreign,Other
Reporter Occupation NOT APPLICABLE
Remedial Action Other
Type of Report Initial
Report Date 02/21/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/01/2013
Device MODEL Number2420-0500
Device Catalogue Number2420-0500
Device LOT Number10095407
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/21/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/23/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
ALARIS PC UNIT: S/N UNK, TX
ALARIS PUMP MODULE: S/N UNK, TX
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