MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IV MONITORING KIT

Model Number 011-46110-58

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Engineering testing and analysis of the used 011-46110-58 transpac monitoring kit confirmed the reported leakage issue.The root cause of the leakage was attributable to the mfg.Assembly/ bonding process.The report concluded there was an insuffcient solvent bond between the safeset reservoir and one-way stopcock sub assy that resulted in a channel leak.Qe testing and analysis of the packaged same lot sample recorded no performance issues and or out of spec conditions.To address these types of intermittent bonding issues, a multi discipline continuous improvement team was formed to perform in depth analysis and investigation of any contributing factors and improvement opportunities.A review of the applicable design, materials, and involved manufacturing and equipment processes was conducted.Detailed reviews of previously implemented improvements relating to assembly bonding operations, equipment and employee training programs were also performed.Functional data obtained from production lots and engineering studies were reviewed.No trends/failures in performance were found.Current status: the initial engineering efforts and team investigations of this component assembly bonding processes recorded mixed findings that were inconclusive.Additional investigation activities and engineering efforts are in progress.As an interim measure, icu medical has implemented 100% nondestructive pull testing and 100% leak testing followed by visual inspection.Current builds reflect these additional heightened testing and inspection processes.

Event Description

Int'l.(b)(6) complaint received reporting leakage and flow issues with use of 011-46110-58 transpac iv monitoring kit.It was reported that ".Safeset kit was set up on patient according to dfu.Comment from nicu nursing staff "line leaking from the join from the syringe to the baby.Significant leak - bleed back on line and affecting trace".The device set was removed and replaced with no further issues encountered.Follow up information confirmed there were no patient injuries, no change in clinical indicators, baseline status, no adverse patient consequences.Device return: one used 011-46110-58 transpac iv monitoring kit and one packaged same lot sample; one unknown mating tubing extension set were returned for analysis and investigation.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: TRANSPAC IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5568603
• MDR Text Key: 42384335
• Report Number: 2025816-2016-00014
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 011-46110-58
• Device Catalogue Number: 011-46110-58
• Device Lot Number: 3078870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1