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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. 8" EXT SET NON-DEHP TUBING

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ICU MEDICAL, INC. 8" EXT SET NON-DEHP TUBING Back to Search Results
Model Number B1371
Device Problem Blocked Connection (2888)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/11/2016
Event Type  malfunction  
Manufacturer Narrative
Visual analysis: 4/4/2016 - received the following devices: one (1) used b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown; one (1) used pump cassette; one (1) used baxter iv bag.Partial device returned, the bag was cut in half.Functional/performance testing: the blood/blood clots were flushed out and decontaminated on the b1371 set.The set was then primed with water using gravity pressure (1.5 psig).And then leak tested with water at 25 psig for two (2) minutes.No leaks were found at the filter set.The one way check valve on the pump set was checked for any back flow at 1.0 psig.No leakage (back flow) was observed through the valve.The tubing pump set was tested for leaks at 10psig for one (1) minute.No leaks were found.The shut off valve also functioned shut off flow.The b1371 device was tested per the product performance specification for iv extension sets.Analysis summary: visual analysis of the "as received" used b1371 complaint sample confirmed blood/blood clots were present in the sets filter components.Following decontamination/flushing the returned sample was tested by engineering to the applicable product specifications and the device performed as intended.With the device performing as intended, the only way for the blood to back flow into the filter is if there was a deliberate disconnect in the line.
 
Event Description
Complaint received regarding one (1) b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown.The report states, blood back up into filter causing pump to stop.Able to flush picc with no difficulty.Neutron cap was in use.Replaced filter and line.There were no adverse patient consequences reported.
 
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Brand Name
8" EXT SET NON-DEHP TUBING
Type of Device
8" EXT SET NON-DEHP TUBING
Manufacturer (Section D)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city UT 84123
Manufacturer (Section G)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city UT 84123
Manufacturer Contact
bob gillispie
4455 atherton dr.
salt lake city, UT 84123
8012641702
MDR Report Key5568387
MDR Text Key42376769
Report Number2025816-2016-00030
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K964435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberB1371
Device Catalogue NumberB1371
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2016
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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