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	09/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Investigation is pending.
Event or Problem Description
The event involved a chemolock that the customer reported the chemo line was apart, and cisplatin was free flowing in the bed.The customer stated the patient rang the bell, and the patient's iv line was apart from the chemolock port on the extension set at the luer end.The "mom" was holding the chemo line so not to expose the line to the environment.The chemotherapy did not directly come into contact with either the patient or the nurse, but there was significant risk of exposure due to the open, and spilled chemo.There was patient involvement of a (b)(6) year old patient, and no adverse event was reported.
Additional Manufacturer Narrative
H10: two (2) list# cl2000s, chemolock injectors (lot# 4876585) were received in opened pouches.Each injector was visually inspected and no damage or anomalies were identified.Each device was manually connected to a chemolock port from icu medical inventory without issue.The two (2) samples were then connected to the chemolock ports provided by the customer and were leak tested.No leaks or disconnections occurred.The returned samples were found to connect and disconnect as designed under normal use conditions.A representative video was provided and evaluated.The video shows a single chemolock injector being manually connected to a chemolock port on a trifuse extension set and then pulled apart without pressing the release clips.No visible damage or anomalies can be seen in the video.The reported complaint can be confirmed based on the video provided.Although the video shows the chemolock devices being separated, the release clips were not pressed.The directions for use state: remove chemolock from the port by grasping and pressing the release clips.Additional follow up with the customer revealed the patients they saw this issue occur with were toddlers who have a tendency to move around and pull on the lines.Therefore, the probable cause is due to an unintentional excessive pulling force applied during use.A device history review for lot# 4876585 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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: 10754075
• Report Number: 9617594-2020-00467
• Device Sequence Number: 11047266
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)250601(10)4876585
• 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,Followup
• Report Date (Section B): 09/24/2020

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: 4876585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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: CISPLATIN, UNK MFR.; QUADFUSE EXT SET, LN CL4123 ICU MEDICAL.; CISPLATIN, UNK MFR; QUADFUSE EXT SET, LN CL4123 ICU MEDICAL
• Patient Age: 3 YR