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
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	09/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.Without the returned device a probable cause is unable to be determined.
Event or Problem 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
• 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
• MDR Report Key: 10656061
• Report Number: 9617594-2020-00437
• Device Sequence Number: 3552120
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)250601(10)4866111
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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 Expiration Date: 06/01/2025
• Device Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 4866111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUADFUSE EXTENSION SET, MFR UNK; UNSPECIFIED CHEMOTHERAPY