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	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.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 a rate of 46ml/hr.The bag was hung on (b)(6) 2018 at 0010 and the leak (from the center of the circular area near the end of the filter) was noted on (b)(6) 2018 at approximately 1115 after infusing for approximately 11 hours.There was no patient harm.
Additional Manufacturer Narrative
The photo provided by the customer confirmed the leak from the micron filter p/n 10012217 on the distal vent hole.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 a rate of 46ml/hr.The bag was hung on (b)(6) 2018 at 0010 and the leak (from the center of the circular area near the end of the filter) was noted on (b)(6) 2018 at approximately 1115 after infusing for approximately 11 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: 8111334
• Report Number: 9616066-2018-02337
• Device Sequence Number: 19265613
• 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,Followup
• Report Date (Section B): 11/02/2018

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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 06/10/2019
• 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) 2018
• Patient Age: 39 YR
• Patient Weight: 68