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U.S. Department of Health and Human Services

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

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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 Back to Search Results
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.
 
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Brand NameONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL
Type of DeviceCLOSED 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 Key10535739
MDR Text Key207218369
Report Number9617594-2020-00399
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131549
Number of Events Reported1
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 Received09/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCL3960
Device Lot NumberUNKNOWN
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 Received08/24/2020
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

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