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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR; SET, EXTENSION, INTRAVASCULAR

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CAREFUSION MICROBORE EXTENSION SET, IV CONNECTOR; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number MZ9226
Device Problems Occlusion Within Device (1423); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)
Patient Problem No Code Available (3191)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative
Conclusion code: field left blank- no available code for undetermined or unknown cause.The customer¿s report that the pump alarmed for occlusion could not be confirmed because the device was not returned for investigation.The report of being unable to manually push medication through the tubing was confirmed.Visual inspection of the set revealed evidence of dried fluid throughout the set¿s components.No obvious damages or other issues were observed.Functional testing resulted in initial resistance until more pressure was applied onto the syringe plunger; then the fluid was able to flow through and exit the distal luer end as expected.The probable cause of the reported event is medication clogging within the tubing.The root cause of the crystallization and clogging is unknown.
 
Event Description
The customer reported that a syringe pump infusing pentobarbital through a peripheral iv alarmed twice for occlusion.The clinician checked the iv, took the syringe out of the pump and tried manually pushing the medication through the tubing without success.The iv was flushed and had a positive blood return.Small crystals were noted in the tubing with the filter.Multiple prn sedation boluses were given over a several hour period in an attempt to better sedate the patient.The customer stated that there was no injury to the patient.
 
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Brand Name
MICROBORE EXTENSION SET, IV CONNECTOR
Type of Device
SET, EXTENSION, 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 Key7101005
MDR Text Key94278177
Report Number9616066-2017-01623
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143234
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 10/30/2017
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 Model NumberMZ9226
Device Catalogue NumberMZ9226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2017
Initial Date FDA Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
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
8110,SYR TUBE,8015,SYRINGE, TD (B)(6)
Patient Outcome(s) Required Intervention;
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