MAUDE Adverse Event Report: ICU MEDICAL INC. TRANSPAC

Model Number	46116-48
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: a review of lot# 3467923 showed (b)(4) units were manufactured, tested, inspected and released in june 2017, citing no applicable exception documents.Engineering evaluation: all oarts met dimensional specifications.Visually there was adhisive in both areas.Engineering summary: the reported product problem for the pressure tubing separation was confirmed.There is presence of uv adhesive at the connection.The dimensions were found within specification.The exact cause cannot be determined at this time.Icu medical is evaluating through continous improvement to implement changes.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding one 46116-48, report states: tubing reportedly pulled out of male distal connector at the catheter site.No adverse patient consequences reported.

• Brand Name: TRANSPAC
• Common Device Name: TRANSPAC
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6848206
• Report Number: 2025816-2017-00201
• Device Sequence Number: 10779443
• Product Code: DRS
• UDI-Device Identifier: 00887709089419
• UDI-Public: 887709089419
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: Nurse
• Device Expiration Date: 06/01/2020
• Device Model Number: 46116-48
• Device Catalogue Number: 46116-48
• Device Lot Number: 3467923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1