MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL3511

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The event involved a 30" (76 cm) appx 3.7 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿, bag hanger, drop-in chemolock¿ port the customer reported that before connection to the patient, the secondary set fell out of the unknown chemotherapy.There was no patient involvement, but there was contamination of the nursing field.There was a delay in therapy due to a need to remix the drug.This is to capture the second of two incidents.

• Brand Name: 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK PORT DRIP CHA
• Type of Device: 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
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9794997
• MDR Text Key: 222133524
• Report Number: 9617594-2020-00064
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL3511
• Device Catalogue Number: CL3511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1