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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS; WARMER, THERMAL, INFUSION FLUID

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CAREFUSION, INC CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number 980202EU
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2017
Event Type  Injury  
Manufacturer Narrative
Initial emdr submission: the customer has confirmed that there is no sample available and the lot number is unknown.If any additional information becomes available a follow up submission will be filed.(b)(4).
 
Event Description
The cartridge is becoming disconnected from the iv line and leaking.It is happening only in preop.Product was used on a patient, there was no patient harm.
 
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Brand Name
CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
HEALTHCARE TECHNOLOGY INTL LTD
yin yang industrial estate, zh
dongguan 53262 0
CH   532620
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6281234
MDR Text Key65871975
Report Number2050001-2017-00047
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number980202EU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2017
Initial Date FDA Received01/26/2017
Was Device Evaluated by Manufacturer? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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