MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3955
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not available for investigation.Without a returned device a probable cause is unable to be determined.
Event or Problem Description
The event involved chemolock bag spike with additive port, chemolock port the customer reported the bag spike dropped out of the bag and was freely funning on the floor from the iv pole.The chemo spill happened to both the nurse and the patient.A spill kit was used.The nurse had it in her hair, soaked her shoes, on her pants, and it was on the patient¿s chair.There was patient involvement, however, no report of patient harm.
Event or Problem Description
Sus voluntary event report(b)(4) was received on (b)(6)2020 stating "cstd dropped out of chemotherapy infusion bag as the nurse was hanging the bag to start infusion.Both the patient and nurse were exposed.The infusion of chemotherapy (carboplatin) was closed using the icu medical cstd, chemolock until the cl-3955 fell out of the bag resulting in approximately 50ml of hazardous solution falling on the nurse, patient, patient's chair and the floor where the nurse was standing.The nurse was able to insert the spike back into the bag to stop flow.The bag/tubing was contained in chemo zip lock bag then returned to the pharmacy for black bucket bulk chemo waste disposal.The pharmacy compounded a second bag for treatment of the patient.".
Additional Manufacturer Narrative
Additional information in sections b5, e3, e4, and g3.H10: no product samples, videos, or photographs were returned for investigation.No device history review (dhr) lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK PORT
• 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: 9729021
• Report Number: 9617594-2020-00048
• Device Sequence Number: 11377719
• Product Code: ONB
• UDI-Device Identifier: 00887709082502
• UDI-Public: (01)00887709082502(17)240801(10)4344340
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 08/01/2024
• Device Catalogue Number: CL3955
• Device Lot Number: 4344340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4) LOT 08032JT EXP 8/01/2021; CARBOPLATIN, MFR UNK