MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. Y-BLOOD 200 FLTR SET+ CLV-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1421828
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for return for evaluation.The reported complaint cannot be confirmed without the returned sample.
Event or Problem Description
The event involved a blood set that was reported to be seen sucking air into the set upon administration of blood products to a patient.There was patient involvement, no adverse event, and no one was harmed as a result of the reported event.

• Brand Name: Y-BLOOD 200 FLTR SET+ CLV-SL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9582627
• Report Number: 9615050-2020-00015
• Device Sequence Number: 374188
• Product Code: FPA
• UDI-Device Identifier: 10887787006459
• UDI-Public: (01)10887787006459(17)220801(10)4144336
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 08/01/2022
• Device Model Number: 1421828
• Device Catalogue Number: 142180488
• Device Lot Number: 4144336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1