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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORP. ALARIS SECONDARY SET
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CAREFUSION CORP. ALARIS SECONDARY SET Back to Search Results
Model Number 10013364
Device Problems Material Separation (1562); Chemical Spillage (2894)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2014
Event Type  malfunction  
Event Description
The customer reported the secondary set tubing separated from the drip chamber.Oxaliplatin in 500 ml d5w was infusing through the secondary set when the separation occurred and resulted in a chemo spill.There was no pt or staff harm reported.Although requested, no additional pt or event details were provided by the customer.
 
Manufacturer Narrative
(b)(4).Unable to determine the cause of the customer's report that the set tubing separated from the drip chamber.The customer stated the set has been discarded and is not available for failure investigation.
 
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Brand Name
ALARIS SECONDARY SET
Manufacturer (Section D)
CAREFUSION CORP.
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd.
san diego, CA 92121
8586176477
MDR Report Key3663137
MDR Text Key4347446
Report Number9616066-2014-00051
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/07/2014
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 Expiration Date09/01/2015
Device Model Number10013364
Device Catalogue Number10013364
Device Lot Number12096653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2014
Initial Date FDA Received01/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2012
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
B. BRAUN PUMP TUBING, MODEL/LOT # UNK
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