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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It has not been received.
Event or Problem Description
The event involved a chemolock that the customer reported at 1:30 pm the patient noticed drips/leakage around the area where it infuses.The unspecified chemotherapy, in a 250 ml bag, appeared to be leaking at the connection of cl2000s and cl2100 at the end of the tubing.The chemotherapy came into contact with the patient and they took action.The remaining 22 ml of chemotherapy was brought back to the pharmacy and they drew up the remaining chemotherapy from the bag in a syringe to administer to the patient.There was some delay in delivering chemotherapy and the chemotherapy spill was cleaned up per facility protocol.There was no blood loss and there were no hole, cut, tears or any defect noted.There was patient involvement and no adverse event nor anyone harmed as a result of the reported event.
Additional Manufacturer Narrative
Received one used list# cl2000s, chemolock.Lot# 5008626, one used i.V tubing set, manufacturer unknown, one used bag spike with chemolock additive port, list# uknown, lot# unknown, one used icu medical container 250 ml 5% dextrose injection, usp.List# 0990-7922-25, lot# 17-402-c6 on february 25, 2021 for evaluation.Leakage was confirmed at the luer to luer connection between the cl2000s chemolock and the male spin luer at the distal end of the unidentified iv infusion set.Close examination revealed cold form impact or scraping damage on the exterior surface of the male luer of the unidentified non-icu medical iv infusion set that resulted in channel leakage at the luer to luer interface.The probable cause of the cold form impact or scraping damage on the exterior surface of the male luer of the unidentified non-icu medical iv infusion set that resulted in leakage cannot be determined.A device history review (dhr) lot# 5008626and 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: 11380652
• Report Number: 9617594-2021-00050
• Device Sequence Number: 3631064
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)250901(10)5008626
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 09/01/2025
• Device Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 5008626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/05/2021
• 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: CHEMOLOCK PORT,ICU MEDICAL CL2100; UNSPECIFIED CHEMOTHERAPY