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

Model Number	42646-06
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: a review of lot# 3337985 showed (b)(4) units were manufactured, tested, inspected and released october 2016 citing no exception documents.Visual investigation: 8/7/2017 received one (1) unused, in an open package 42646-06, transpac iv monitoring kit, safeset reservoir, 2 blood sampling ports 84" tubing, disposable transducer; lot# 3337985.The as received 42646-06 set was unused and there was no mating device was returned.The unused 426460406 device was visually examined and found no anomalies present.The 17" pressure tubing connection at the 3-way stopcock was also examined under microscope (10x) and found no anomalies present like cracks, deformities or insufficient uv adhesive at the female luer/ pressure tubing bond when examined under a black light.Functional testing: the unused 426460406 device was primed with water at gravity pressure and then leak tested at 9.0 psig for 1 minute.No leaks occurred at the hand tightened connection between the male luer of the 3 way stopcock and female luer of the 17" pressure tubing.Also there was no leakage at the pressure tubing bond of the female luer.Pressure tubing bond was pull tested (specification: bond must withstand 6.0 lbs.Minimum pull): 17.9 lbs.(tubing broke).Final analysis summary: the reported product problem for separated connection could not be replicated/confirmed with the unused 42646-06 device.The bonded connection did not leak or separate and they met specification.Also the hand tightened connection at the 3 way stopcock did not leak and the luer tapers met the iso standard for luer tapers.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding one 42646-06, transpac iv monitoring kit.Report states: patient had l.Femoral arterial line that broke off at 3-way stopcock, where the tubing fits into the luer.Pressure bag became ineffective.Clamped off the line and replaced it with a new arterial line with no further issues.No adverse patient consequences reported.

• Brand Name: TRANSPAC IV MONITORING KIT
• Common Device Name: TRANSPAC
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6778249
• Report Number: 2025816-2017-00186
• Device Sequence Number: 210356
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: 840619028053
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: 10/01/2019
• Device Model Number: 42646-06
• Device Catalogue Number: 42646-06
• Device Lot Number: 3337985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1