MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-PC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a spinning spiros® closed male luer, purple cap.The customer reported that the device disconnected/separated and then leaked during patient infusion of methotrexate.The exact location of the leakage was from where the spiros disconnected from the line and the chemo leaked out of the giving set.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel; spills were always cleaned as per local policy using a spill kit.Interventions relating to patient included changing lines and making a plan for lost chemotherapy.When asked if the set was replaced and therapy resumed without any problem, the customer stated that it depended on the chemotherapy and situation; if possible, different lines were used however this was often not feasible due to loss of chemotherapy in the line itself so it had to be cleaned and reconnected which goes against recommended best practice for central line cares and infection prevention.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
It is unknow if the device is available for evaluation; device history is pending.
Additional Manufacturer Narrative
No ch2000sc-pc product samples, videos or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.The device history record was reviewed and there were no non conformances found that would have contributed to the reported complaint.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20347521
• Report Number: 9617594-2024-01367
• Device Sequence Number: 12714041
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270201(10)5824001
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2024

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: CH2000S-PC
• Device Lot Number: 5824001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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: METHOTREXATE, MF UNK; METHOTREXATE, MFR UNK; UNSPECIFIED IV/GIVING SET MFR UNK
• Patient Sex: Unknown