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

Catalog Number	CL2100
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved a chemolock¿ port that was reported to be pulling from both the primary bag and the secondary bag at the same time during infusion.The product had been used before the issue was noticed.There was no leaking from the device.The issue resulted in prolonged infusion time and a delay in therapy.There was no report of human harm associated with this complaint/event.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.A video was provided by the customer and evaluation of the video is pending.
Additional Manufacturer Narrative
A video was provided by the customer showing an unknown extension set and a chemolock connected into a bd alaris pump.On the set-up, is observed how drops of solution fall into the drip chamber.However, no flow issues or anomalies on the video were observed.The customer's complaint of unintended concurrent flow cannot be confirmed based on the video shared by the customer.The chemolock itself is not responsible for the events described on the complaint.The chemolock icu medical device, works as a connector not as a flow control regulator.The device history record was reviewed and no non-conformities were found that would have led the reported condition/complaint.

• Brand Name: CHEMOLOCK¿ PORT
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18038311
• Report Number: 9617594-2023-00897
• Device Sequence Number: 12644991
• Product Code: ONB
• UDI-Device Identifier: 00887709057005
• UDI-Public: (01)00887709057005(17)280301(10)13567951
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/10/2023

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 Catalogue Number: CL2100
• Device Lot Number: 13567951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: ALARIS PUMP, MFR BD; UNSPECIFIED INFUSATES (2), MFR UNK; UNSPECIFIED PRIMARY INFUSION BAG, MFR UNK; UNSPECIFIED SECONDARY INFUSION BAG, MFR UNK
• Patient Sex: Unknown