MAUDE Adverse Event Report: ICU MEDICAL, INC SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, SPIROS

Model Number	CH3147
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple chemo leakage incidents with use of ch3147 60" smallbore ext.Set with microclave spiros connections.It was reported that there have been three incidents where ch3147 set leakages originating "on outside of spiros where bonded" occurred; the chemo drugs were identified as rimotecan and doxanubicin.No patient involvement, prior to use.
Additional Manufacturer Narrative
Received 10 unused unit of ch3147 60" set w/microclave, spiros connectors, lot 262892.One uses unit with attached microclave, one used ch2000s spinning spiros, lot unk, and a 12ml monoject syringe that contained a red drug.Investigation: the used ch3147 was pressure leak tested @5psi and the spiros leaked.A microscopic examination of the spiros showed that the o-ring was dislodged.The other (b)(4) ea ch3147 were pressure tested and all passes in the activated and unactivated positions.The team identified several improvements on the press, test operations and welder station processing sequences, the automated assembly process now has a sensor that verifies the presence and proper placement of the o.

• Brand Name: SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, SPIROS
• Common Device Name: SPIROS
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr.; salt lake city UT 84123
• 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 ; 600 n. field dr; lake forest, IL 60045
• MDR Report Key: 19554767
• Report Number: 2025816-2014-00165
• Device Sequence Number: 12463927
• Product Code: FPA
• UDI-Device Identifier: 00840619033941
• UDI-Public: (01)00840619033941(17)180101(10)2626892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2014

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: 01/01/2018
• Device Model Number: CH3147
• Device Catalogue Number: CH3147
• Device Lot Number: 2626892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2014
• 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: 01/01/2013
• 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: 12ML MONOJECT SYRINGE.
• Patient Sex: Unknown