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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION GRA SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION GRA SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number C42014E-07
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2015
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
Customer reported that the tubing is stiff and it makes it difficult to control the flow with the roller clamp.The customer reported that the clamp on a patient was set to kvo, the clamp came opened and 700 ml of iv fluids ran in.No patient harm reported.
 
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Brand Name
GRA 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key5192138
MDR Text Key29978774
Report Number9616066-2015-01420
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTN
PMA/PMN Number
K820278
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 10/20/2015
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 NumberC42014E-07
Device Catalogue NumberC42014E-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2015
Initial Date FDA Received10/30/2015
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
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