MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. 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 Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is available for evaluation.Investigation is pending.The extension to the phone number is ext (b)(6).
Event or Problem Description
The event involved a chemolock that did not connect to the nursing port causing a leak of chemotherapy.There was patient involvement and no human harm.
Event or Problem Description
Additional information received: the nurse connected the intravenous (iv) line to the patient with the chemolock and started the chemotherapy treatment.After it had been infusing for about 5 minutes, the patient reported a wet feeling on her arm.The nurse saw a couple of drops on her arm and immediately stopped the pump, and washed the patient's arm with soap.The patient's clothes and floor were dry.There was a leak between the iv line and the lock.The nurse changed to a new chemolock and checked if there were any leaks with a saline flush.Treatment was restarted and no further trouble or leaks were noticed.The nurse was wearing proper ppe.
Additional Manufacturer Narrative
-a photo was returned showing an incomplete connection between a chemolock port and a chemolock injector.-two used cl2000s chemolock injectors (lot #5849726) were returned for investigation.-no mating chemolock ports were returned to evaluate with the used cl2000s chemolock injectors.The two used cl2000s chemolock injectors (lot #5849726) were successfully and securely connected to known good chemolock ports lot (lot #4448181).Subsequent pressure leak testing showed the cl2000s chemolock injectors (lot #5849726), though not fully connected to the cl2100 chemolock ports, met product performance expectations without leakage.The complaint was unable to be confirmed with the cl2000s chemolock injectors (lot #5849726) that were returned for investigation.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional entries can be found in a5 and a6.Additional information can be found in h6 - adverse event problem, health effect - clinical code.

• Brand Name: CHEMOLOCK¿
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14567433
• Report Number: 9617594-2022-00146
• Device Sequence Number: 5096138
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)270401(10)5849726
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2022

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 Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 5849726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 06/28/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOLOCK¿ PORT (L# CL2100), ICU MEDICAL MFR; UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Female