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

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.

Event Description

The event occurred on an unknown date in (b)(6) 2020.The customer reported a chemolock injector falling off at the luer end of an alaris set resulting in significant chemo spills.Nurses are noticing that certain patients, toddlers between 2-5 who are active and mobile, receiving chemotherapy are experiencing these disconnections.There was patient involvement, but no harm reported.This report captures the first of two events.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The device history review for lot number 4876585 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.

Event Description

Additional information was received.The chemolock injector unhooked from the chemolock port on the quad fuse line while running iv cisplatin.The chemo line was discovered off of the patient as soon as the pump rang occlusion.The tubing was replaced and it resolved the problem.

• Brand Name: CHEMOLOCK
• Type of Device: 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: 10736556
• MDR Text Key: 213191710
• Report Number: 9617594-2020-00461
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 4876585
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALARIS PRIMARY SET.