MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
Event or Problem Description
A sus voluntary medwatch report (#mw5095106) was received and stated that a "spiros closed system transfer device on doxorubicin syringe leaked when rn started to administer to patient x 2.New dose syringe and spiros provided by pharmacy and dose was administered without leaking.Also had leaking spiros chemolock set.¿ the product involved was a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger.The issues noted were found to be leaking during priming in some instances but also during administration.If noted during priming, the product was remade prior to dispensing.There were no component damages or abnormalities observed on the device.Additionally, the customer reported the device was connected to a bd alaris pump infusion set (w/3 smartsite y-sites) during administration.The most distal y-site was used.No harm was reported.This report is for the spiros chemolock set.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK DRIP CHAMBER,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10396848
• Report Number: 9617594-2020-00313
• Device Sequence Number: 14120967
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)250201(10)4720479
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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 Expiration Date: 02/01/2025
• Device Model Number: CL3011
• Device Catalogue Number: CL3011
• Device Lot Number: 4720479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1