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

Catalog Number	CL2000S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device photos were provided for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a chemolock generated a leak during patient use.The reporter stated that the leaking of chemotherapy was noticed between the chemolock port cl2100 and chemolock injector cl2000s.There was no sample return available to be tested, the sample was discarded.There was no same lot device sample available and no mating device available to be tested.Sample photos were provided; the first two photos showed a leak that caused a chemotherapy spill, and the third photo showed the blue clave of the primary set.There was no blood loss, no unprotected chemo exposure, no delay in critical therapy, no med/surg intervention required and the device changed out/replaced with no further problems encountered.There was no patient harm reported.
Additional Manufacturer Narrative
Three photos were shared by the customer, first two photos showed a leak that caused chemotherapy spill, and the third photo showed the blue clave of the primary set.No additional damage or anomalies are observed.The complaint of chemotherapy leakage can be confirmed based on the photos shared by customer.However, since no product sample was returned for investigation, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record was not reviewed, as no lot number was provided.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20474584
• Report Number: 9617594-2024-01467
• Device Sequence Number: 7612212
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: 00887709056992
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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 Catalogue Number: CL2000S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CL2100, MFR UNK; UNSPECIFIED CHEMO, UNK MFR; UNSPECIFIED CHEMO, UNK MFR
• Patient Sex: Unknown