MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Spinning Spiros®, Closed Male Luer; set, administration, intravascular

Catalog Number	CH2000S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros, closed male luer reported that patient's tubing and spiros became disconnected.Spiros does not appear to be damaged.Upon arrival to unit, blood cultures drawn, new bag and tubing primed and reconnected to patient.Patient required 20ml ns flush to get blood return for blood cultures.Staff attempted different methods to get blood return prior to flushing with no success.Spinning spiros and tubing of blina double bagged, saved with cytotoxic sticker.The event occurred during infusion.There was a patient involvement but no patient harm.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.

• Brand Name: Spinning Spiros®, Closed Male Luer
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50817937
• Report Number: 9617594-2026-01302
• Device Sequence Number: 18803551
• Product Code: FPA
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903(17)291201(10)14237423
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 14237423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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