MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10012144
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer¿s complaint of tubing leak was confirmed.During visual inspection it was noted that the distal smartsite p/n 12274436 near the male luer had damage to the piston p/n 10026585.Further evaluation under microscope, noted that the rubber piston p/n 10026585 had two puncture holes.No other anomalies were observed on any of the other two smartsite components.Functional and pressure testing identified leaking at the distal smartsite port near the male luer.The root cause of the leak was a damaged smartsite piston.The cause of the damage to the smartsite piston was a puncture from a needle or similar sharp object that resulted in permanent holes in the piston material.
Event or Problem Description
The dialysis nurse noted that the tubing was leaking out of the port closest to the patient connection.The patient's 100ml calcium gluconate infusion was dripping out instead of infusion for 1 hour and blood from the patient's catheter was back flowing out of the same port.The patient became hypokalemic, symptomatic, and had a small amount of blood loss.Although requested, there were no further details or information provided and no report of lasting harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8782423
• Report Number: 9616066-2019-01847
• Device Sequence Number: 1937564
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: 10012144
• Device Catalogue Number: 10012144
• Device Lot Number: 18076961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR