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 second of two events.

Manufacturer Narrative

H10: additional information in b3, d4, and h4.Subsequent to the initial submission, the customer contact reported this event is the same event that was reported under mfr # 9617594-2020-00467, therefore is a duplicate submission.The investigation results will be submitted in the supplemental medical device report for mfr # 9617594-2020-00467.

• 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: 10736510
• MDR Text Key: 213194029
• Report Number: 9617594-2020-00462
• 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
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALARIS PRIMARY SET.