MAUDE Adverse Event Report: ICU MEDICAL INC 30" 20 DROP ADMIN SET W/SPIROS

Model Number	20124-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Engineering testing and analysis: the returned 20124-01 admin set components were leak tested per the applicable product specifications.The results recorded the admin sets spiros connector in the unactivated position, leaked at low pressure (36" head pressure).Additional analysis: the 20124-01 admin set affected components were disassembled and evaluated.The results recorded y-clave silicone plug was damaged on top surface; additionally various spike damages were found that were characteristic with connections with incompatible mating device.The spiros connectors poppet exhibited some deformation at the tip.Findings: engineering evaluations of the returned 20124-01 device set/affected componentry did confirm a leakage issue with the spiros/y-clave connection.Detailed analysis of the involved component manufacturing and assembly processes which included equipment, inspections and work instructions was performed.Cont.Pg.3 other remarks the team identified several improvements focusing on the press, test operations and welder station processing operational sequences.The automated assembly process now has a sensor that 100% verifies the presence and proper placement of the componentry (o-ring on the female luer).The work flows were modified, additional detailed assembly instructions were implemented and affected employee training was performed.
Event or Problem Description
Int'l.(canada)complaint received regarding leakage issues with one 20124-01 30" 20 drop spiros admin set.It was reported that "leaking discovered during back.

• Brand Name: 30" 20 DROP ADMIN SET W/SPIROS
• Common Device Name: ADMIN 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: 19554706
• Report Number: 2025816-2014-00160
• Device Sequence Number: 20511041
• Product Code: FPA
• UDI-Device Identifier: 00840619023331
• UDI-Public: (01)00840619023331(17)180301(10)15-081-HE
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2013

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
• Device Expiration Date: 03/01/2018
• Device Model Number: 20124-01
• Device Catalogue Number: 20124-01
• Device Lot Number: 15-081-HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2013
• 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
• 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: 100ML SALINE BAXTER BAG.; 341ML BBRAUN BAG.; UNK MFGER SYRINGE.; UNK MFGER./ PUMP TUBING LINE.
• Patient Sex: Unknown