MAUDE Adverse Event Report: ICU MEDICAL 7" (18 CM) APPX 0.40 ML, SMALLBORE BIFUSE EXT SET 7" (18 CM) APPX 0.40 ML, SMALL

Model Number	CH3379
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received regarding one ch3379.Report states: while administering viscristine with the bifuse tubing the medication began leaking out of the connection from the tubing to the patient's mediport.It did not get on the patient but a drop or two fell on her mom's hand.She immediately and thoroughly washed her hands and no irritation was noted.No adverse patient consequences reported.
Additional Manufacturer Narrative
Lot review: a two 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.Visual inspection: received one (1) used 7" (18 cm) appx 0.40 ml, smallbore bifuse ext set w/1 microclave® clear, w/2 spiros®, 2 clamps: lot# unknown, one (1) used chemoclave bag spike; lot# unknown, one (1) used spinning spiros; lot# unknown, one (1) used baxter 25ml empty bag primed with 0.9% sodium chloride and viscristine and one (1) used 20ml bd syringe.Engineering sunctional testing: the following fluid circuit was returned for investigation: bifuse line 1: iv bag -->ch-10 bag spike --> spinning spiros --> bifurcated adapter --> male luer --> spinning spiros bifuse line 2: 30ml bd syringe --> spinning spiros --> shuntless microclave --> bifurcated adapter --> male luer --> spinning spiros.The entire fluid path (less the proximal spinning spiros and ch-10 bag spike) was pressure leak tested.No leakage at any location along the fluid path.The syringe was securely connected to the spinning spiros.The 30ml syringe was removed from the spinning spiros and the entire fluid circuit (including the proximal spinning spiros and ch-10 bag spike) was pressure leak tested.No leakage was observed at any location along the fluid path.Engineering summary: the components returned for investigation of leakage were pressure leak tested and the entire fluid circuit met pressure leak expectations outlined in the product performance specification.Unable to confirm complaint.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding one ch3379.Report states: while administering viscristine with the bifuse tubing the medication began leaking out of the connection from the tubing to the patient's mediport.It did not get on the patient but a drop or two fell on her mom's hand.She immediately and thoroughly washed her hands and no irritation was noted.No adverse patient consequences reported.

• Brand Name: 7" (18 CM) APPX 0.40 ML, SMALLBORE BIFUSE EXT SET 7" (18 CM) APPX 0.40 ML, SMALL
• Common Device Name: 7" (18 CM) APPX 0.40 ML, SMALLBORE BIFUSE EXT SET 7" (18 CM) APPX 0.40 ML, SMALL
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84123
• MDR Report Key: 6759694
• Report Number: 2025816-2017-00155
• Device Sequence Number: 13732024
• Product Code: FPA
• UDI-Device Identifier: 00840619066543
• UDI-Public: 840619066543
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: CH3379
• Device Catalogue Number: CH3379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1