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

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient: last initial (b)(6).Concomitant medical products: broviac( 4.2 french ) catheter; bd 3ml syringe, therapy date: (b)(6) 2018.Baby's, race white.Initial (b)(6) (unable to determine if moms initial or doctor initial).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 a continuous 24hr.Infusion of versed (5.5kg/1mg/ml) at a rate of 0.3ml/hr., the tubing was found leaking right at the connection of the set and the ¿disc¿ referencing disc as filter.It was reported that the set was attached to the patient's broviac 4.2 fr.Catheter, placement at the baby¿s right chest wall.The facility went live a couple of months with the filter set however in the past 2 weeks the nicu has noticed several filter extension set complaints.Although requested the customer did not indicate any patient harm noted.The event occurred in nicu.
Additional Manufacturer Narrative
Additional information provided: patient weight.The customer¿s report of a leak at the filter was confirmed.Visual inspection of the set noted no damage or any anomalies.Closer inspection of leak under magnification observed traces of insufficient solvent at the engagement.Functional testing confirmed leaking at the engagement of the tubing and the distal end of the filter, near the filter outlet.The tubing was measured and found to be within measurement specification.The root cause of the customer¿s report of leaking at the filter is due to insufficient solvent at the engagement between the filter outlet and tubing.
Event or Problem Description
It was reported that during a continuous 24hr.Infusion of versed (1mg/1ml) at a rate of 0.3ml/hr., the tubing was leaking at the connection of the iv set and the ¿disc¿ (presumed to mean the filter).The iv was the set was attached to the baby's broviac 4.2 fr.Catheter, at the baby¿s right chest wall.The facility went live a couple of months ago with the filter set however in the past 2 weeks the nicu has noticed several filter extension set leaks.Although requested the customer did not indicate any patient harm.The event occurred in nicu.Although requested, no further information or details of the event were given.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8242229
• Report Number: 9616066-2019-00058
• Device Sequence Number: 1929135
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Model Number: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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,SYR TUBE,8110,SYRINGE, TD (B)(6) 2018
• Patient Age: 5 MO
• Patient Weight: 6