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

Model Number	2232-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer report of a possible leak was confirmed based on functional and pressure testing in which it was observed that fluid leaked out (termed ¿weeping out¿) from the vent of the filter.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leak 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.As the leak was reported to be observed during use and not during priming, it is unlikely that the leak was the result of a manufacturing or supplier issue.
Event or Problem Description
It was reported that the rn found the tubing set filter leaking during patient use.The tubing set was cleaned and dried to find that it continued to leak with no visible cracks found in the filter.The customer later stated that there were no adverse effects caused to the child patient from the event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8893040
• Report Number: 9616066-2019-02308
• Device Sequence Number: 19247115
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: 10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 2232-0007
• Device Catalogue Number: 2232-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2019
• 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: 8100, 8015, THERAPY DATE (B)(6) 2019