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

Model Number B1371

Device Problem Blocked Connection (2888)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

Visual analysis: (b)(4) 2016 - received two (1) - one used one new b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown.No mating devices were returned.Blood and a clot was observed in the used filter.The filter was flushed without issue.Functiona'/perfomrance testing: the used set the blood/blood clots were flushed out and decontaminated.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 packaged (unused) set was primed with water using gravity pressure (1.5 psig).The set was then leak tested with water at 25 psig for two (2) minutes.No leaks were found at the filter set.The two (2) devices were tested per the product performance specification.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 b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown.The report states, "client on hpt program.Client noted blood in proximal tubing and filter of picc line.Previous occurrence this week requiring filter change by rn.Client came back to clinic with obvious clotting present.Unable to aspirate or flush picc line.Client sent to er for tpa instillation for occluded picc.No serious adverse consequences reported.

• Brand Name: 8" EXT SET NON-DEHP
• Type of Device: 8" EXT SET NON-DEHP
• 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 Key: 5568375
• MDR Text Key: 42386036
• Report Number: 2025816-2016-00029
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• 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 Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: B1371
• Device Catalogue Number: B1371
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1