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

Model Number	C24101E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 not returned for failure investigation.The root cause of this failure was not identified.The event occurred at (b)(6) hospital; therefore it is presumed the patient was a child.
Event or Problem Description
The customer reported a leak at the filter when infusing tpn at an unspecified rate.It was reported that the filter leaks started in (b)(6) 2018.The customer stated that "there was a product backorder of this product at the beginning of (b)(6), and not sure if this has anything to do with the issue." the event occurred at (b)(6) hospital.Although requested there was no additional event details or customer did not indicate any patient harm.
Additional Manufacturer Narrative
Bifuse non bd set icu medical, therapy date unk.
Event or Problem Description
The customer reported multiple tpn filter leaks which started in october 2018.The rn reported that the tpn rates vary from patient to patient, the set up included a trifuse (bd set) or bifuse (non bd set) connected to a port or picc line.The leaks all occur around the backside of the filter when the set is in use from 12- 96 hrs.The events are occurring in either med / surg or critical care.The customer did not indicate patient harm however reported an interruption in care.The rn reported the technique of priming the filter was in accordance with the instruction for use.

• 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: 8224611
• Report Number: 9616066-2018-02636
• Device Sequence Number: 13501983
• Product Code: FPA
• UDI-Device Identifier: 10885403235528
• UDI-Public: 10885403235528
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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 Model Number: C24101E
• Device Catalogue Number: C24101E
• 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: 01/07/2019
• Supplement Report FDA Received Date: 02/08/2019
• 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: ME1021,8100,8015,PICC LINE, TD UNK