MAUDE Adverse Event Report: ICU MEDICAL, INC. NEUTRON

Model Number 081-NC100

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

Lot review: a two (2) year review of the complaint database for this list/similar problem did record additional reports and investigations.A review of those investigations where devices were returned recorded mixed results, including no defect found; usage; cannot determine and mfg./ design.Receipt verification :5/9/2016 - received four (4) used 081-nc100, neutron, lot# unknown.No mating devices were returned.The silicone seal of one neutron was confirmed to be split.Functional testing: four used 081-nc100 neutron connectors were returned for investigation of leakage.Close visual examination revealed that each of the four 081-nc100 neutron connectors had seal tearing on the top surface.Most had damage that extended to the edge of the top surface resulting in leakage.Each of the four 081-nc100 neutron connectors were disassembled.The spikes and housings on all four did not show signs of damage or anomalies.The only damage was to the top surface of the silicone seals.Analysis summary: the complaint of leakage from the four 081-nc100 neutron connectors returned for investigation was confirmed.The leakage was the result of damage sustained to the top surface of the silicone seal in the form of tearing.No mating devices were returned to evaluate with the 081-nc100 neutron connectors.The exact cause of the silicone seal tearing is not known.

Event Description

Complaint received regarding one 081-nc100, neutron, lot# unknown.Report states "air contamination after changed the infusion set and neutron, the air contamination was stopped.It looked like silicon plug had an issue." no serious adverse patient consequences reported.

• Brand Name: NEUTRON
• Type of Device: NEUTRON
• 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: 5670997
• MDR Text Key: 45706416
• Report Number: 2025816-2016-00043
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 081-NC100
• Device Catalogue Number: 081-NC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• 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: Reuse
• Patient Sequence Number: 1