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

Model Number	2429-0500
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
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 during an infusion of d5 with sodium bicarbonate at 125ml/hr, the tubing was found with a split and leaking at the blue clamp that is placed in the pump.Although requested, there are no further details that have been provided.
Event or Problem Description
The customer reported that during an infusion of d5 with sodium bicarbonate at 125ml/hr, the tubing was split and leaking at the upper fitment.Although requested, there are no further details that have been provided.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing split and leaked was confirmed.Visual inspection of the set noted a tear on the area of the silicone segment located atop the edge of the upper fitment component.No further damages or issues were observed.Functional testing confirmed leaking from the observed tear.The cause of the leak was due to a tear in the silicone segment.The root cause of the leak is unknown.

• 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: 8306477
• Report Number: 9616066-2019-00273
• Device Sequence Number: 16154940
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 18105653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015, THERAPY DATE (B)(6) 2019; 8100,8015, THERAPY DATE (B)(6) 2019
• Patient Age: 82 YR