MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number CL3960

Device Problems Fluid Leak (1250); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation. Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined. A device history review could not be completed due to the unknown lot number.

Event Description

The event involved an oncology kit w/60" (152 cm) appx 2. 2 ml, smallbore ext set w/chemolock¿ port, clamp, anti-siphon valve, spiros¿; chemolock¿; syringe transfer set w/microclave¿, chemolock¿ port, that separated during a home infusion of 5fu, while using a cadd pump. The extension set was attached to the cadd pig tail and the y-site was used for the medication infusion into the cadd. At an unspecified time during the infusion, the y-site of the tubing separated and the treatment could not resume. The tubing set was replaced. There was no blood loss or bleed back reported. The chemo medication did not come into contact with the patient or health care provider and the chemo spill was cleaned up per facility protocol. There was patient involvement, no adverse event nor anyone harmed as a result of the reported event.

• Brand Name: ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10535739
• MDR Text Key: 207218369
• Report Number: 9617594-2020-00399
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CL3960
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2020
• 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