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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ5309
Device Problems Fluid/Blood Leak (1250); Kinked (1339); Split (2537)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that the extension tubing is forming an indentation/kink when clamped then splitting in the middle of the loop where the indentation was and leaking.The radiology department was injecting isovue contrast for a ct angiogram with a psi no greater than 325 and pushed the medication at a maximum of 6ml/sec when this happened.There was no patient harm.
 
Event Description
The customer reported that the extension tubing is forming an indentation/kink when clamped then splitting in the middle of the loop where the indentation was and leaking.The radiology department was injecting isovue contrast for a ct angiogram with a psi no greater than 325 and pushed the medication at a maximum of 6ml/sec when this happened.There was no patient harm.
 
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Brand Name
MAXZERO EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7603107
MDR Text Key111142023
Report Number9616066-2018-00834
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ5309
Device Catalogue NumberMZ5309
Other Device ID Number10885403242083
Was Device Available for Evaluation? No
Date Manufacturer Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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