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

Model Number CL3520

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a 40" (102 cm) appx 5.2 ml, admin set w/2 chemolock¿ w/red cap, 20 drop in-line drip chamber, bag hanger.The customer reported that they had a chemo spill due to a cracked secondary set.There was no report of patient involvement or patient harm.

Manufacturer Narrative

The device has been received.Pending investigation.

Event Description

Additional information was received from the customer stating the actual device involved was an alaris infusion set with a chemolock¿ port attached at the end.The customer stated that the device cracked where the line sits inside the pump, where the soft plastic sits inside the pump meets the hard plastic, at either the top or the bottom.This caused the pump to get wet and shut down.The chemo came into contact with the patient.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

Received one used list #cl2100, chemolock¿ port; lot #unknown, one bd alaris pump set, and one unknown catheter and hub were received and visually inspected.As received, no visible damage or anomalies were identified.Connected as received, the returned samples were leak tested through the chemolock port.Leakage occurred through a tear in the bd alaris tubing.The chemolock port was disconnected from the alaris set and leak tested.No damage, anomalies or leaks were identified on the chemolock port.The reported complaint of leakage from the chemolock port was not confirmed.The leakage observed occurred from a tear in the bd alaris tubing (non-icu medical device).The probable cause of the tear is unknown.A dhr lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: CHEMOLOCK¿ PORT
• 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: 13685775
• MDR Text Key: 290091921
• Report Number: 9617594-2022-00047
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL3520
• Device Catalogue Number: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED ALARIS INFUSION SET; UNSPECIFIED CHEMOTHERAPY, UNK MFR