MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL2000S-10

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event occurred on an unspecified date and involved a chemolock¿ unit that was reported to be involved in a chemotherapy leak.The part of the transfer device that clicks onto the syringe did not click and did not secure/lock.As the nurse began to push an injection into the iv line, 5-fu sprayed from the connecting site where the transfer device attaches to the syringe.It was noted that the transfer device could be completely removed from the syringe and was unable to be clicked or locked into place.There was no harm reported.

Manufacturer Narrative

The complaint of leakage and unable to connect on the chemolock¿, 10 units was evaluated.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation could not be performed and a cause could not be determined.Additional information can be found in sections b5, d9 and h6 health effect - clinical code.

Event Description

Additional information was received stating that there was patient involvement and that chemotherapy was sprayed onto the patient.The chemotherapy was cleaned according to the facility's protocol using a spill kit.The drug was replaced and therapy was resumed as an intravenous (iv) push.Further, the sample was immediately disposed because it was covered in chemotherapy.

• Brand Name: CHEMOLOCK¿, 10 UNITS
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12682475
• MDR Text Key: 282215034
• Report Number: 9617594-2021-00283
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL2000S-10
• Device Catalogue Number: CL2000S-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5-FU, MFR UNK; UNSPECIFIED IV LINE, MFG UNK; UNSPECIFIED SYRINGE, MFR UNK