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	11/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint of leak at the back of the filter was confirmed from a photo provided by the customer.The customer¿s photo was evaluated and the reported event of leaking filter was observed to be leaking from the distal vent hole from the micron filter.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that a leak occurred in the oncology unit during a pump infusion of a 500ml bag of normal saline containing etoposide 62.5mg, doxorubicin 12mg, and vincristine 0.35mg which was running at 46ml/hr.The bag was hung on (b)(6) at 0251 and the leak at the low sorb infusion set with filter /texium was noted on (b)(6) at 1220.Specifically, the leak was coming from the back of the filter where there is a circular part of the plastic.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: 8115467
• Report Number: 9616066-2018-02348
• Device Sequence Number: 11157823
• Product Code: FPA
• UDI-Device Identifier: 10885403240980
• UDI-Public: 10885403240980
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/04/2018

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 Expiration Date: 04/30/2021
• Device Model Number: 24602-B007T
• Device Catalogue Number: 24602-B007T
• Device Lot Number: 18046755
• 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: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 68