MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE MODULE; SET,ADMNISTRATION,INTRAVASCULAR

Model Number	10014916
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products:lumen picc line, 3ml zr flush syringe; syringe; syringe tube td (b)(6) 2018.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 that the tubing separated at the filter when infusing tpn.The set up included medication line attached to tpn line attached to patient¿s single lumen picc line.It was reported that the user noted blood back flow on picc line.The user stated that all clamps were unclamped and there were no occlusion alarms noted on the device.The charge nurse was called to patient bedside and upon further examination found the medication line broke/separated at the filter.There was no report of patient harm.There was no report of patient harm.The event occurred in the nicu.
Event or Problem Description
The customer reported that the tubing separated at the filter when infusing tpn.The set up included medication line attached to tpn line attached to patient¿s single lumen picc line.It was reported that the user noted blood back flow on picc line.The user stated that all clamps were unclamped and there were no occlusion alarms noted on the device.The charge nurse was called to patient bedside and upon further examination found the medication line broke/separated at the filter.There was no report of patient harm.The event occurred in the nicu.
Additional Manufacturer Narrative
Lot number is unknown, disregard expiration date and manufacturing date from initial report.Patient was an infant.Although information for a.2, and a.4 were requested, the information was not provided by the customer.The customer report that the tubing separated at the filter was confirmed.Visual inspection showed a separation at the engagement between the filter outlet and the microbore tubing components.Microscopic inspection identified insufficient solvent application at he filter engagement, as well as the tubing depth was not fully inserted within the filter component.Functional testing showed no anomalies.The identified root cause was due to a manufacturing assembly issue of insufficient solvent at the tubing engagement.

• Brand Name: ALARIS SYRINGE MODULE
• Common Device Name: SET,ADMNISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8044513
• Report Number: 9616066-2018-02148
• Device Sequence Number: 1463826
• 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
• Report Date (Section B): 10/11/2018

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 Expiration Date: 08/21/2021
• Device Model Number: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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: 10014916,(1)SYR TUBING,TD (B)(6) 2018; 8110,8015,EXT TUBING,MZ1000-07, TD (B)(6) 2018