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

Model Number	2447-0007
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	12/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was an infant (nicu).No other demographics were provided.Cont concomitant medical products: non bd set, bag 4, 2 non-bd swab caps.The customer's report of crack and leak near the upper fitment was confirmed.Visual inspection identified a 0.1215 inch tear in the upper silicone segment near the upper fitment.Microscopic inspection noted a crush mark to the upper fitment.Functional and pressure testing confirmed the leak in the same location.The root cause of the tear could not be determined.
Event or Problem Description
The customer reported that the smartsite burette infusion set cracked near the upper fitment and leaked tpn in the nicu; as a result, the infant did not receive their scheduled tpn dose.A note attached to the received product stated the tubing was punctured inside the pump, and noticed when the pump was being cleared.The infant received a full iv fluid and tubing change, as well as a dose of prophylactic vancomycin.

• 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: 8276695
• Report Number: 9616066-2019-00150
• Device Sequence Number: 11089493
• Product Code: FPA
• UDI-Device Identifier: 10885403235078
• UDI-Public: 10885403235078
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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 Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2019
• 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: 8015,8100,TD (B)(6) 2018
• Outcome Attributed to Adverse Event: Required Intervention