MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK® W/RED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL2000S-RC
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received the following.New samples: set #1- one (1) bd alaris pump infusion burette set.Set #2- eleven (11) list #cl3964.Set #3- seven (7) list #cl2000s-rc.Used samples: set #1- one (1) extension set with filter.Set #2- two (2) bd alaris pump infusion set 0.2 micron filter connected with two (2) chemolocks list #cl2000s-rc.Set #3- one (1) bd alaris pump infusion set back check valve set #4- one (1) list #unknown, bag spike adapter connected with one (1) chemolock non-spinning.Set #5- one (1) list #cl2000s-rc.As received, in all the chemolocks a good shear tab activation and no damage on the splines were observed.The chemolock assemblies mechanics were correctly activated, the residual torque of the chemolocks were found to be within specifications.The female luer of the chemolocks and the male luer of the mating devices were confirmed to comply with iso design expectations.Complaint of disconnection / loose can be confirmed based on the evaluation of the chemolocks evaluation.However, after evaluated the chemolocks and the mating device nothing wrong was confirmed with them.The probable cause of the disconnection is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a chemolock® w/red cap where it was reported that the customer was having regular disconnections between cl2000s and their bd alaris tubing during patient use.They discarded the product in question, but they were able to recreate the concerns they were having with their tubing and cl2000s, which can be sent in for review.Other products involved at time of event: bd tubing with list number 2432-0007 and ext tubing with list b9061 and lot 13671625.The product was in use for 18 hours.Additionally, the customer stated that they found a patient disconnected from their line with drug and blood leaking out.Medication involved was blinatumomab.The event occurred at 4pm.There was patient involvement, no harm/adverse event, and there was delay in therapy.

• Brand Name: CHEMOLOCK® W/RED CAP
• 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: 18053693
• Report Number: 9617594-2023-00923
• Device Sequence Number: 17620740
• Product Code: ONB
• UDI-Device Identifier: 00887709091887
• UDI-Public: (01)00887709091887(17)280401(10)13596168
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/04/2023

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: CL2000S-RC
• Device Lot Number: 13596168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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 TUBING (LIST #2432-0007), BD; BLINATUMOMAB, MFR UNK; EXT TUBING (LIST #B9061 & LOT #13671625), ICU MED
• Patient Sex: Unknown