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

Model Number	2232-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: two spiros adapters (two alcohol caps).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.Patient age and dob requested but not provided, however, the customer stated that they are a pediatric facility, therefore, it is presumed that the patient was a pediatric patient.
Event or Problem Description
It was reported the tubing set filter leaked during a methotrexate infusion with an approximated 25cc's of medication lost during use on a pediatric patient.
Additional Manufacturer Narrative
The customer¿s report that the tubing set filter leaked was confirmed.Testing only observed a leak (termed ¿weeping out¿) from the vents of the filter component.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.Visual inspection for obvious issues/damage such as kinked tubing, pin holes, tears, disengagements, cracks, fractures, contaminants, incorrect orientation, and component disassembly was completed.No obvious issues were observed with the received samples.The root cause of the observed leak from the filter vents was not identified.
Event or Problem Description
It was reported the tubing set filter leaked during a methotrexate infusion with an approximated 25cc's of medication lost during use on a pediatric patient.Although requested, there is no additional information available.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMIN, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8967157
• Report Number: 9616066-2019-02474
• Device Sequence Number: 2088653
• 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,Followup
• Report Date (Section B): 08/08/2019

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 Expiration Date: 11/14/2021
• Device Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: 18115901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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