MAUDE Adverse Event Report: ICU MEDICAL ONCOLOGY KIT WITH SPINNING SPIROS; ADMIN SET

Model Number	CH3581
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.Reported lot 3456323 (mfg date 5/2017) was manufactured and released with no exception documents cited.
Event or Problem Description
Etoposide special tubing connected to spiros connector was transfusing.The patient overextended and the iv tubing and the spiros snapped from the connector.Approximately 15ml of the drug spilled.Unprotected chemo exposure was reported.

• Brand Name: ONCOLOGY KIT WITH SPINNING SPIROS
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 7044795
• Report Number: 2025816-2017-00237
• Device Sequence Number: 1901421
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: 887709079243
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: Health Professional
• Device Model Number: CH3581
• Device Catalogue Number: CH3581
• Device Lot Number: 3456323
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1