MAUDE Adverse Event Report: ICU MEDICAL INC SETSOURCE PRIMARY DROP SET

Model Number	Z3054
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2013
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received reporting leakage issues with use of z3054, 94" primary drop set w/bcv-clave, clave, 3 gang 1o2, lot# unknown.It was reported that "product set in pre-op, in or setting (3 gang 1o2) manifolds have leaked[?] in all situations the procedure has been completed and the tubing taken off after surgery.".There were no reported adverse patient consequences and or outcomes.Device return: one used z3054 device set attached to unknown ext.Set and a total of six packaged z3054 device sets from "potential" lot# were received engineering testing and analysis was performed.The returned used z3054 and the six unused z3054 device sets were tested to the applicable product specifications.The results recorded for the used z3054 confirmed leakage was replicated originating from the distal port on the sets 3 gang 1o2 manifold.
Additional Manufacturer Narrative
Engineering testing and analysis cont.: the results for the unused z3054 show leakage originating from the 1o2 port(s) was replicated on two of the returned samples.There were no leakages, and or performance issues found with the remaining four unused z3054 device sets.Findings: engineering testing and analysis of the returned z3054 device sets confirmed the reported leakage/1o2 manifold product issue with three of the seven returned z3054 device sets.Detailed analysis of the involved component(s) design attributes, materials, mfg./equipment were performed.The teams efforts/relevant data focused on design and molding specifications and the improvements to minimize potential variables.Heightened inspection criteria including tighter concentricity callouts were implemented as an interim measure.The team identified, qualified and validated modifications to the welding process where extensive data studies identified tighter (crack) specifications would reduce potential retrograde.

• Brand Name: SETSOURCE PRIMARY DROP SET
• Common Device Name: SETSOURCE PRIMARY DROP 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: 19554700
• Report Number: 2025816-2014-00155
• Device Sequence Number: 12440255
• Product Code: FMG
• UDI-Device Identifier: 00887709029330
• UDI-Public: (01)00887709029330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2013

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 Model Number: Z3054
• Device Catalogue Number: Z3054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2013
• Is the Reporter a Health Professional?: Yes
• 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
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK MFGER SYRINGE
• Patient Sex: Unknown