MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL2000S-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The event occurred at 5:00pm at the patient¿s home and involved an issue with a chemolock and chemolock port and an unprompted disconnect of the ambulatory pump resulting in unprotected chemo exposure to doxorubicine.It was reported that the device was in use an hour when a droplet was noted and therapy was halted.The set up was a piggyback and there were no issues noted during initial set-up/priming.There is patient involvement, and although there was a report of a delay in therapy, there was no adverse event and no one was harmed as a result of the reported event.This report reflects the first of five events reported.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The device history review was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: CHEMOLOCK, 10 UNITS
• 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: 11407683
• Report Number: 9617594-2021-00058
• Device Sequence Number: 11887833
• Product Code: ONB
• UDI-Device Identifier: 00887709071735
• UDI-Public: (01)00887709071735(17)250901(10)5008582
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 09/01/2025
• Device Model Number: CL2000S-10
• Device Catalogue Number: CL2000S-10
• Device Lot Number: 5008582
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/29/2021
• 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: CHEMOLOCK¿ PORT, LN CL2100, MFR ICU MEDICAL; DOXORUBICINE, MFR UNK.; UNSPEC AMBULATORY PUMP, MFR UNK.