MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK ADDITIVE PORT, VENTED CAP; CHE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3538
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used list# cl3538, oncology kit w/5" (13 cm) add-on set w/chemolock¿ additive port, vented cap; chemolock¿; spinning spiros¿ w/red cap.Lot# 4765922, one extension set, manufacturer unknown, one used 250 ml bag 0.9% sodium chloride injection, usp, one used universal vented vial spike, list# unknown, lot# unknown, one used vial 16 ml docetaxel injection, usp was returned for evaluation.The reported complaint of leakage can be confirmed.The leakage occurred from the broken spike of the additive chemolock port.The chemolock port was disassembled and the tip of the spike was confirmed to be broken.Blush was evident on the spike.No other damage or anomalies were seen on the remaining components of the port.It is unknown when and how the spike became broken.No mating devices that would interface with the chemolock port were returned.A device history review (dhr) lot# 4765922 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a oncology kit w/5" (13 cm) add-on set w/chemolock¿ additive port, vented cap; chemolock¿; spinning spiros® w/red cap that the customer reported an unspecified chemotherapy medication leaking specifically with from the chemolock bag spike component of the kit out from a mating device.The leaking occurred immediately after the drug was added to the bag.The tubing set up was the 5" add-on-set spiked into bag, unspecified tubing set connected to add-on-set, and ch-2000sc attached to the end of the tubing.The chemotherapy spill was cleaned up per protocol and there was no spill kit used.There was no patient involvement and no adverse event.
Additional Manufacturer Narrative
The probable cause of the broken chemolock spike is due to an automated assembly error.The list and lot number of the device was identified as part of a voluntary recall.Icu medical is notifying affected customers via a letter requiring removal of the affected products from the market.

• Brand Name: ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK ADDITIVE PORT, VENTED CAP; CHE
• 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: 10244145
• Report Number: 9617594-2020-00219
• Device Sequence Number: 16750629
• Product Code: ONB
• UDI-Device Identifier: 00887709071902
• UDI-Public: (01)00887709071902(17)250401(10)4765922
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 04/01/2025
• Device Model Number: CL3538
• Device Catalogue Number: CL3538
• Device Lot Number: 4765922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1