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

Model Number	10014916
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported fluid leaked from a crack in the luer on the syringe pump tubing during an infusion of tpn on a nicu patient.The leak occurred at the connection between a 1 ml syringe, the tubing, and a needleless connector.There was no report of patient harm.
Additional Manufacturer Narrative
The patient was an infant.The customer¿s report that fluid leaked from a crack in the luer was confirmed.Visual inspection found a crack in the female luer wall on the opposite end of the injection gate of the suspect filter extension set.Functional testing showed that the set leaked from the cracked female luer.No tool marks or signs of over torque were observed.The root cause of the crack could not be identified.
Event or Problem Description
It was reported that a leak occurred from a crack on the luer of the syringe pump tubing while infusing tpn in the nicu.The leak occurred at the connection between the 1 ml syringe, tubing, and a needleless connector.There was no report of patient harm.
Additional Manufacturer Narrative
Correction on initial report: adverse event ( disregard disability).
Event or Problem Description
It was reported that a leak occurred from a crack on the luer of the syringe pump tubing while infusing tpn in the nicu.The leak occurred at the connection between the 1 ml syringe, tubing, and a needleless connector.There was no report of patient harm.

• Brand Name: ALARIS SYRING MODULE SET
• Common Device Name: SET,ADMINISTRATION,SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8313692
• Report Number: 9616066-2019-00356
• Device Sequence Number: 16675805
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2019

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 Model Number: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 06/03/2019; 06/10/2019
• 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: 8015,8110, MZ1000-07,1 ML BD SYR, TD (B)(6) 2018.
• Outcome Attributed to Adverse Event: Disability