MAUDE Adverse Event Report: ICU MEDICAL INC. TRANSPAC IV W/SAFESET RESV MTG KIT

Model Number	46103-68
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device return: one used 46103-68 mtg.Kit.Visual inspection (pre and post decontamination) of the as-received used 46103-68 mtg kit verified the tubing was separated from the bonded female luer component.Qe analysis of the affected 011-46103-68 segment recorded there was a complete solvent ring/bond around the tubing and the tubing/pocket insertion depth was correct.Dimensional analysis of the affected components recorded no out of spec conditions.Findings: the reported product issue (component separation) was visually confirmed with the "as-received" used 011-46103-68 mtg.Kit.The 46103-68 mtg kit had been pre-tested/primed with no issues detected prior to placement.Although the exact cause(s) of the component separation are unknown the engineers report determined the most likely cause was attributable to unintended force/tension at this connection possibly during pt.Movement, repositioning and or transport.Icu medical will continue to monitor and trend these types of reported product issues and initiate preventative measures as applicable.
Event or Problem Description
Complaint received reporting component separation with use of one 46103-68 transpac iv w/safeset resv mtg kit.The initial information received reports at an unspecified time after placement the 46103-68 mtg.Kits ".Pressure tubing disconnected from the female luer (location marked with a fentanyl sticker).The female luer remained connected to the 3-way zeroing stopcock".The device was removed and replaced.There were no reported adverse patient consequences.Additional information although requested by the manufacturer was not available.

• Brand Name: TRANSPAC IV W/SAFESET RESV MTG KIT
• Common Device Name: TRANSPAC IV W/SAFESET RESV MTG KIT
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6722740
• Report Number: 2025816-2017-00166
• Device Sequence Number: 1615781
• Product Code: DRS
• UDI-Device Identifier: 00887709050723
• UDI-Public: 00887709050723
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2017

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: 46103-68
• Device Catalogue Number: 46103-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 07/18/2017
• Patient Sequence Number: 1