MAUDE Adverse Event Report: ICU MEDICAL INC. ONCOLOGY KIT W/SPINNING SPIROS

Model Number	CH3581
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: a review of lot# 3456323 showed (b)(4) units manufactured, tested, inspected and released in may 2017 citing no exception documents.Receiving inspection: received one (1) used ch3581, oncology kit w/spinning spiros®, c-clip, red cap; lot# 3456323.One (1) new ch3581, oncology kit w/spinning spiros®, c-clip, red cap; lot# 3456323.One (1) new ch3581, oncology kit w/spinning spiros®, c-clip, red cap; lot# 3374555.One (1) new smartsite infusion set (carefusion).The as received one ch3581 sample was primed and spinning feature wasn't activated.Functional testing: each of the returned ch3581 spinning spiros were connected to the new smartsite infusion pump set (10015645).The connection, residual, and disconnect torque values were measured and met product specification.Qe analysis summary: the ch3581 spinning spiros were all returned without the spin features activated.Each of the ch3581 spinning spiros were securely connected to the smartsite infusion pump set (b)(4) male luer when the spin feature was activated during connection.All spiros met product specification and did not disconnect when attached.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding one ch3581.Report states: chemo leak happened between primary tubing and spiros.No adverse patient consequences reported.

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS
• Common Device Name: ONCOLOGY KIT W/SPINNING SPIROS
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6794442
• Report Number: 2025816-2017-00189
• Device Sequence Number: 120861
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: 887709079243
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• 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): 08/15/2017

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: 05/01/2022
• Device Model Number: CH3581
• Device Catalogue Number: CH3581
• Device Lot Number: 3456323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 70