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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CARTRIDGE DISPOSABLE 3IN EXT SET STERILE; WARMER, THERMAL, INFUSION FLUID

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CAREFUSION CARTRIDGE DISPOSABLE 3IN EXT SET STERILE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number 980202EU
Device Problems Crack (1135); Leak/Splash (1354); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2015
Event Type  Injury  
Event Description
The customer put a stopcock on the enflow cartridge.The propofol infusion medication was not coming to the patient and the patient was moving a little, so they removed the stopcock directly from the cartridge to the venflon.This appeared to resolve the problem.The operation was successfully completed.The hospital changed the protocol after this incident and they do not give medication anymore directly behind the cartridge but only on the venflon or line.Additional information was obtained from the customer on (b)(6) 2015.The customer attached some pictures to illustrate how they set up the infusion system to the cartridge in the first place when the problems occurred.The hospital has now changed the protocol.The new protocol is a different set up of the cartridge and the use of medication, analgesia and the enflow cartridge.They now place the stopcock system between the cartridge and the patient.After they changed this protocol the problem with the cartridge did not occur anymore.The patient did not receive the medication (propofol) and analgesia because there was no proper connection to the infusion line (which was the main iv line).The enflow cartridge was damaged and medication was leaking from the enflow cartridge before entering the patient.The customer confirmed that there was no problem with the stopcock.There was just only a crack in the enflow cartridge so medication and infusion fluid was leaking.When the problem was found, the damaged enflow cartridge was replaced by a new enflow cartridge.There was only one infusion line.On the infusion line there was placed a stopcock system and at the end of the infusion line there was placed an enflow cartridge.The fluid was running warmed to the patient.
 
Manufacturer Narrative
(b)(4) the customer has stated that the device is not available for evaluation by carefusion.In addition the lot number of the device is unknown.The customer was unable to provide any pictures of the defective device.A follow-up mdr submission will be performed should the device or additional information become available.
 
Manufacturer Narrative
This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Corrected data: pt identifier, adverse event and/or product problem, outcomes attributed to adverse events, type of reportable event.Additional info: evaluation codes, manufacturing facility.(b)(4).
 
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Brand Name
CARTRIDGE DISPOSABLE 3IN EXT SET STERILE
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
CAREFUSION
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
HEALTHCARE TECHNOLOGY INTL LTD
yin yang industrial estate, zh
dongguan, guangdong 53262 0
CH   532620
Manufacturer Contact
jill rittorno
75 north fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key4681258
MDR Text Key5622552
Report Number2242551-2015-00023
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K130867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,company represent
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/20/2016
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 Other Health Care Professional
Device Model Number980202EU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/06/2015
Initial Date FDA Received04/10/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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