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

Model Number	24602-B007T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Admitting diagnosis: double-hit lymphoma (double hit dlcbl).Relevant history: appears to be the 1st cycle.Although requested, information on race and ethnicity were not provided.
Event or Problem Description
It was reported from the oncology floor, during a 24 hour etoposide 120mg/doxorubicin 24mg/vincristine 0.4mg in 500ml normal saline infusion, the filter leaked.The event occurred on the last day of the 4 day cycle.Upon inspection, the leak appeared to be coming from the "pinholes" on the side of the filter.Gauze was wrapped around the filter to stop the leak.The bag and tubing set were changed about every 22 hours.There was no patient harm.

• 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: 10051073
• Report Number: 9616066-2020-01647
• Device Sequence Number: 11503510
• Product Code: FPA
• UDI-Device Identifier: 10885403240980
• UDI-Public: 10885403240980
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 12/04/2022
• Device Model Number: 24602-B007T
• Device Catalogue Number: 24602-B007T
• Device Lot Number: 19125501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 63