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	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Concomitant medical products: mz1000-07, therapy date (b)(6) 2018.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that a alaris syringe module set was leaking unspecified fluids at the connection to the filter.It was reported by the customer that the "medication line" suspect set was replaced with a new set.There was no report of patient harm.The event occurred in nicu.
Additional Manufacturer Narrative
Cont'd from a.1: baby girl.The customer¿s report of a leak at the connection to the filter was confirmed.Visual inspection of set noted no damage or any anomalies.Examination under magnification identified insufficient solvent applied at the engagement between the pvc tubing and the filter outlet.Functional testing confirmed leaking from the same location.The tubing was measured to be within measurement specification.The root cause of the report of leaking from the filter was due to insufficient solvent at the engagement between the filter outlet and tubing.
Event or Problem Description
The customer reported a syringe module set leaked at the connection to the filter during an unspecified nicu infusion.The set was replaced and there was no patient harm.

• 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: 8076350
• Report Number: 9616066-2018-02248
• Device Sequence Number: 1721722
• 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): 10/24/2018

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: 11/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 8110,8015,PRI TUBING,SYRINGE, TD (B)(6) 2018