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

Model Number	10012283
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.Requested patient demographics.
Event or Problem Description
It was reported that the burette tubing leaked fluids at an unspecified location.Although requested customer stated; " i don¿t have specifics for each" there was no additional event details provided.A note attached to product fluids initiated on 10/07 and leaking 10/09.The event occurred in the nicu.
Additional Manufacturer Narrative
The customer¿s report that the burette tubing leaked fluids was confirmed and replicated on the primary set.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Yellowish colored liquid was observed in the set¿s burette and entire length of tubing.Orange alcohol disinfecting caps were attached to all three of the set¿s smartsites.No abnormalities were observed on the set during visual inspection.The filter vents were inspected under a microscope for holes/tears in the filter membrane or damage to the filter housing.Visual inspection observed no damage to the filter¿s membrane or housing.Functional testing observed leaking out of both filter vents on the set¿s micron filter.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leaking was due to clog/oversaturation of filter and the time of use from which the fluid flow was restricted.The fluid then seeks the path of least resistance through the filter vent.
Event or Problem Description
It was reported that the burette tubing leaked fluids at an unspecified location.Although requested, customer stated; " i don¿t have specifics for each", and there was no additional event or patient details provided.A note attached to product fluids; initiated on "10/07 and leaking 10/09".The event occurred in the (nicu).

• 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: 9298400
• Report Number: 9616066-2019-03159
• Device Sequence Number: 468814
• Product Code: FPA
• UDI-Device Identifier: 10885403233692
• UDI-Public: 10885403233692
• 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: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 10012283
• Device Catalogue Number: 10012283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: 3 ORANGE CAPS, THERAPY DATE (B)(6) 2019.