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	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a spinning spiros® closed male luer, purple cap where the customer reported that several times (unspecified quantity) the spiros became disconnected during patient after a few minutes use with chemotherapy (dinutuximab) in pediatrics.Someone became aware of the event due to leakage in the bed and noticed a loose connection.The customer stated that there was no visible damaged on the set that caused the disconnection.The exact location of the leakage was from where the spiros disconnected from the line and chemo leaks out of the giving set.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel, however, the spills are always cleaned as per local policy using a spill kit.Interventions relating to patient included changing lines and making a plan for lost chemotherapy.The customer was asked if the set was replaced and therapy resumed without any problem, and the customer stated that it depended on the chemotherapy and situation; when 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.The product was not contaminated or contain biohazard or chemotherapeutic agent.The product was not reprocessed or re-sterilized prior to use.There was patient involvement, no patient harm, there was delay in therapy and no one was harmed as a result of the reported event.
Additional Manufacturer Narrative
Received three (3) new.List #ch2000s-pc, spinning spiros® closed male luer, purple cap; lot #5824001 and three (3) new.List #unknown, needlefree luer activated valve; lot #74862.No visual damages or anomalies were observed.The spiros was tested as per procedure and no internal/external leaks or disconnections were observed.Complaints of leaks or disconnections cannot be confirmed during the test.The returned spiros and mating devices were connected as described and no leaks or disconnections were observed during testing.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may 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: 20334098
• Report Number: 9617594-2024-01361
• Device Sequence Number: 8004206
• Product Code: ONB
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DINUTUXIMAB, MFR UNK; NEEDLREE CONN/CODAN - LIST # BC 123N/LOT #74862
• Patient Sex: Unknown