MAUDE Adverse Event Report: ICU MEDICAL INC. ADMINISTRATION SET; ADMIN SET

Model Number	CL3520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect lot review: a review of suspect lot 3451193 shows that 2,400 units were manufactured, tested, inspected and released in may 2017 citing no exception documents.A review of suspect lot 3046159 shows that 150 units were manufactured, tested, inspected and released in may 2015 citing no exception documents.Receiving inspection: received one (1) used cl3520, 40" (102 cm) appx 5.2 ml, admin set w/2 chemolock¿, 20 drop in-line drip chamber, bag hanger;suspect lot# 3451193.The as received cl3520 set has residuals of chemodrug.The chemolock connector (one close to drip chamber) leaked at the seam (where chemolock body connects to clear collar).Functional testing: the used cl3520 was primed and when primed a leak was observed at the spin collar of the chemolock connector.The chemolock connector was disassembled with the following observations: o-ring was missing.Final summary: the chemolock connector at the proximal end of the cl3520 set was leaking.The cause of the leakage was a missing o-ring.Icu medical has notified qa and manufacturing for their heightened awareness and employee training.Icu medical will continue to monitor and trend.
Event or Problem Description
Complaint received regarding one cl3520, report states: chemotherapy was hung using the chemo lock secondary set (cl3520).As soon as the secondary set was attached to the chemo bag it stated leaking where the tubing attaches to the blue connector above the drip chamber.It was a continuous drip until the nurse detached the cl3520 from the chemo bag and replaced it with another cl3520 and leakage discontinued.Proper ppe was utilized.No patient involvement or adverse consequences reported.

• Brand Name: ADMINISTRATION SET
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6984725
• Report Number: 2025816-2017-00225
• Device Sequence Number: 10925018
• Product Code: ONB
• UDI-Device Identifier: 00887709057036
• UDI-Public: 887709057036
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: CL3520
• Device Catalogue Number: CL3250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1