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 (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 back-order 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.
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 current technique of priming the filter: "ensure roller clamp is closed, spike bag, fill chamber, ensure filter is upright and not inverted, open roller clamp to allow fluid to flow into tubing, once primed to the end, close the roller clamp and pinch clamp between the patient and the filter, attach to bifuse/trifuse and continue with set up of pump and starting infusion.".
Additional Manufacturer Narrative
Picc line;bifuse - (non bd set icu medical).The customer complaint of leak at filter could not be confirmed because the product was not returned for failure investigation.The customer¿s provided a photo of the set-up by holding up the micron filter by hand were it appeared to be leaking from.No issues were observed per photo provided.The root cause of this failure was not identified as no product was returned.

• 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: 8224651
• Report Number: 9616066-2018-02653
• Device Sequence Number: 1670302
• 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: No Information
• 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: ME1021,8015,8100, TD UNK