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
Concomitant medical products: cook catheter/picc lines; icu medical micro clave connector; icu medical 90 in small bore bifuse & trifuse, therapy date: 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.The events reportedly occurred in multiple units; hem/onc/bmt, burn unit, neurosurgery, plastic surgery, trauma unit, picu, and ent patients ; therefore it is presumed the patients were adults/child.
Event or Problem Description
During a site visit by a bd representatives, the staff reported issues since (b)(6) 2018 with tpn filters leaking at various times within 45 mins to 90 hrs.Of a tpn infusion.It was reported that the tpn is changed every 96 hrs., the facility is using multiple manufacturer disposables.There was no reported patient harm.The events are occurring in multiple units; hem/onc/bmt, burn unit, neurosurgery, plastic surgery, trauma unit, picu, and ent patients.

• 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: 8438811
• Report Number: 9616066-2019-00812
• Device Sequence Number: 277330
• 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
• Report Date (Section B): 02/21/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1