MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S.A. DE C.V. CHEMOLOCK¿; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL2000S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The evaluation has not yet begun.
Event or Problem Description
Staff attached the set up to the chemolock extension port which was attached to the patients primary tubing (alaris non-dhep).A leak of epirubicin from the center of chemo lock connector between syringe and a port was noted by the nurse.A small amount of drug trickled down patient¿s arm, but stayed contained to blue pad and the arm was cleaned as per skin care guidelines.There were no concerns with patient¿s skin.There was no adverse event and no delay in critical therapy.
Additional Manufacturer Narrative
Device was returned for evaluation bent and broken.The single used chemolock was connected to a syringe, but the luer connetion was bent at an acute angle.Subsequent evaluation revealed that the male luer of the syringe was broken inside the female luer of the used chemolock, which would result in fluid leakage.The used device was tested for pressure leak (hydro-statically) and met the pressure leak performance specification.The probable cause of the leakage could not be determined.

• Brand Name: CHEMOLOCK¿
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S.A. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8143255
• Report Number: 9617594-2018-00219
• Device Sequence Number: 13690489
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)230701(10)3736434
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 07/01/2023
• Device Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 3736434
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1