MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET; SET, INFUSION, INTRAVASCULAR

Model Number	11612593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
The customer reported that the tubing set had a hole, as well as, the filter was leaking during patient use.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of a hole in the tubing was confirmed.The report of a leaking filter was not confirmed.Examination under magnification showed 2 short, rough-edged cuts approximately 8¿ below the lower fitment.The 2 cuts together formed a v shape, similar to what would be observed after forceps or another clamping instrument had been used.Leaks were noted from the 2 holes, but no leaking from the filter was observed.The cause of the damage and leaking was determined to be the use of forceps or a similar clamping instrument.
Event or Problem Description
The customer reported that the tubing set had a hole, as well as, the filter was leaking during patient use.There was no patient harm.

• Brand Name: ALARIS INFUSION SET
• Common Device Name: SET, INFUSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7687399
• Report Number: 9616066-2018-00995
• Device Sequence Number: 16302268
• Product Code: FPA
• UDI-Device Identifier: 10885403283963
• UDI-Public: 10885403283963
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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 Model Number: 11612593
• Device Catalogue Number: 11612593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1