MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS

Model Number	CH2000S-PC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received on 04/15/2014 three used and 2 unused ch2000s.
Event or Problem Description
Issue noticed during preparation (france).The liquid went into the body of the spiros and leaked.There were no adverse patient consequences reported.

• Brand Name: SPIROS
• Common Device Name: SPIROS
• 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 (Section G): 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 ; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 19554764
• Report Number: 2025816-2014-00166
• Device Sequence Number: 12463926
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)141101(10)1803212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/03/2014

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: 11/01/2014
• Device Model Number: CH2000S-PC
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 1803212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2009
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2009
• 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: 1ML BD SYRINGE; 2ML BD SYRINGE
• Patient Sex: Unknown