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
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.The event occurred at children's 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 children's 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);picc line; td unk.No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
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.
Additional Manufacturer Narrative
The customer¿s report of leaking from the filter was confirmed.Visual inspection showed no anomalies.Functional testing was performed; upon priming, small droplets were noted to be leaking from both the top vent and bottom vent of the filter.The root cause of the leak was determined to be oversaturation of the filter which causes the infusate to leak/weep out through the path of least resistance (the filter air vent).
Event or Problem Description
The customer reported multiple tpn filter leaks which started in (b)(6) 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: 8224817
• Report Number: 9616066-2018-02657
• Device Sequence Number: 10828941
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/04/2019; 03/08/2019
• 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: ME1021,8015,8100, TD UNK