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 Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.Without the returned device a probable cause is unable to be determined.

Event Description

The event involved a chemolock that the customer reported when they went to check on a patient to complete their assessment it was discovered a line unattached from the patient.The unspecified chemotherapy was infusing freely into the bed.The chemotherapy possibly was on the patient, but it was not on the healthcare provider.The customer reported the chemolock cap was no longer attached to the iv line and was also no longer attached to the patient's quadfuse extension set.The whole line had to be changed and the line's worth of chemotherapy was lost.There was no physical defect noted on the cap and the chemo spill was cleaned up per facility protocol.There was patient involvement and minimum harm to the patient was reported because of the delay in chemotherapy.There was no blood loss or bleed back.

• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10656061
• MDR Text Key: 210669131
• Report Number: 9617594-2020-00437
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)250601(10)4866111
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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: 4866111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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: QUADFUSE EXTENSION SET, MFR UNK; UNSPECIFIED CHEMOTHERAPY