MAUDE Adverse Event Report: ICU MEDICAL INC. TRANSPAC

Model Number	46112-05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis: received one partial set, used 46112-05, transpac® iv trifurcated monitoring kit w/03 ml squeeze flush device, arterial safeset¿ reservoir and needleless valves; lot# is unknown.The female luer, winged, red is disconnected from reservoir safeset, custom 15" pt tbg.Engineering evaluation: the separated connection male luer on the stopcock and the red female luer met the iso standards.Engineering summary: the reported product problem for the pressure tubing separation bonds were confirmed.The 15" tubing separation from the red female there was a solvent ring present.The 36" tubing separation there is presence of uv adhesive at the bonded connection.The exact cause could not be determined at this time since there was solvent/adhesive present at the separated connections.In addition the dimensions were found within specification.Icu medical through continuous improvement is looking at any improvements that can be made.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding two 46112-05, report states: the pressure tubing on this triple transducer kit pulled loose from the luer.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: 6848052
• Report Number: 2025816-2017-00197
• Device Sequence Number: 13640928
• Product Code: DRS
• UDI-Device Identifier: 00887709062085
• UDI-Public: 887709062085
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other Health Care Professional
• 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 Model Number: 46112-05
• Device Catalogue Number: 46112-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• 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