MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS¿, CLOSED MALE LUER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000S
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a spinning spiros® closed male luer, red cap that experienced disconnection during infusion.It was stated in the report that they arrived at a scheduled appointment to disconnect continuous infusion of blinatumomab, line las changed 1 week prior, line was infusing and intact, but patient stated line came apart at the junction of the spinning spiros closed male luer at the end of the solution set, closest to the patient.This piece typically locks once applied.Patient stated they witnessed it come apart and they immediately reconnected it and it stayed.They returned equipment to hospital and were able to easily remove the spinning spiros.They did not lock the infusion set.Impact of incident: the patient was stable, and the infusion was completed.There was a potential risk to the patient for infection, as there was a break in the line attached to a central line.The event occurred on 25-sept-2024.There was patient involvement and event occurred during infusion.There was no patient harm and no delay in therapy.
Additional Manufacturer Narrative
E tab initial reporter - the complaint came through: (b)(6).Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Additional information in b5 and g2.
Event or Problem Description
Additional information received on16-dec-2024 stating that this complaint was originally reported by a home patient and no more information can be gathered.
Additional Manufacturer Narrative
Received one (1) used.List #ch2000s, spinning spiros¿, closed male luer; lot #unknown.--> one (1) used.List #unknown, lsm cassette with tubing and filter; lot #unknown.--> one (1) used.List #unknown.--> one (1) used.List #unknown, bag spike adapter with chemolock; lot #unknown.As received, some residuals noted in the tubing set, also noted, the tubing has separated from the luer, no damage or anomalies observed with the spiros.Customer complaint of spiros is easily removed cannot be confirmed.

• Brand Name: SPINNING SPIROS¿, CLOSED MALE LUER
• 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 ; CA 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20641201
• Report Number: 9617594-2024-01581
• Device Sequence Number: 7443347
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: 00840619033903
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2025

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
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 02/13/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/13/2025; 02/18/2025
• 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
• Patient Sex: Unknown