MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, CYLINDER PUMP, CLAVE Y-SITE, SECURE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142190488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone has an extension number (b)(6).Received one used list #142190488 primary y-type blood set.As received the blood filter cylinder was observed to have a vertical crack.The complaint 'tubing was broken and leaking' can be confirmed due to the crack observed.The probable cause of the crack is unknown.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
The event occurred on an unspecified date involving a primary y-type blood set, 200 micron filter, cylinder pump, clave y-site, secure lock, 80 inch.It was stated in a report that the customer had primed the tubing in preparation for blood transfusion.There were no issues at the time.When they returned from break, her covering partner, who hung the blood, stated that the pump section of the tubing was broken and leaking, and they had to change the tubing.The device was pre-tested before use and not re-sterilized or re-processed.The event occurred during a transfusion.There was patient involvement but no reported injury or harm.

• Brand Name: PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, CYLINDER PUMP, CLAVE Y-SITE, SECURE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19956503
• Report Number: 9615050-2024-00594
• Device Sequence Number: 21057149
• Product Code: FPA
• UDI-Device Identifier: 10887787009146
• UDI-Public: 10887787009146
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143087
• 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
• Report Date (Section B): 08/09/2024

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: 142190488
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 08/09/2024
• 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