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 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Investigation is pending.

Event 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.

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
• 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
• MDR Report Key: 10754075
• MDR Text Key: 213660710
• Report Number: 9617594-2020-00467
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)250601(10)4876585
• Combination Product (y/n): N
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 4876585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CISPLATIN, UNK MFR.; QUADFUSE EXT SET, LN CL4123 ICU MEDICAL.; CISPLATIN, UNK MFR; QUADFUSE EXT SET, LN CL4123 ICU MEDICAL
• Patient Age: 3 YR