MAUDE Adverse Event Report: ICU MEDICAL INC IV/EXT ADMIN SETS/ACC; IV PRIMARY SET

Model Number	Z0020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used and two unused z0020, 109" 15 drop clave w/remv 3 gang 1o2 primary sets lot# 27-764-he.The used set was only the 1o2 manifold.Lot review showed no anomalies with this production.Investigation: the distal port of the used exhibited retrograde leakage at 5 psi and the other two ports did not leak.Sample one of the unused units exhibited retrograde leakage at the distal port at 5 psi and the other two ports had no leakage.Sample two exhibited no retrograde leakage at any ports.Based on these investigation results a continuous improvement team was initiated to further evaluate and determine product performance enhancements to address these type of intermittent component (flow/leakage) issues.
Event or Problem Description
Leaking at or around the 3 port 1o2 manifold.Customer does have one affected manifold to return and two unused units.There were no adverse patient consequences reported.

• Brand Name: IV/EXT ADMIN SETS/ACC
• Common Device Name: IV PRIMARY SET
• Manufacturer (Section D): ICU MEDICAL INC; 600 n. field dr; lake forest IL 60045
• Manufacturer (Section G): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa., 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 19554701
• Report Number: 2025816-2014-00156
• Device Sequence Number: 12440256
• Product Code: FMG
• UDI-Device Identifier: 00887709020009
• UDI-Public: (01)00887709020009(17)180301(10)27764HE
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2013

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: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: Z0020
• Device Catalogue Number: Z0020
• Device Lot Number: 27-764-HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1O2 MANIFOLD.
• Patient Sex: Unknown