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

Model Number	11609481
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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.
Event or Problem Description
The customer reported that the stretchy part that is inserted into the pump had a hole in the tubing and the tpn was leaking out while in the nicu.There was no harm.
Event or Problem Description
The customer reported that there was a hole in the segment of the tubing that is inserted into the pump, resulting in a leak.The event occurred in the nicu with tpn infusing at 8 ml/hr.There was no patient harm.
Additional Manufacturer Narrative
No product received greater than 45 days.No product will be returned per customer.The customer complaint of hole in silicone segment and leaked could not be confirmed due to the product was not returned for failure investigation.The customer provided a photo of a set inside its packaging package.No issues were observed per photo received by the customer.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
The customer reported that there was a hole in the segment of the tubing that is inserted into the pump, resulting in a leak.The event occurred in the nicu with tpn infusing at 8 ml/hr.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: 8241528
• Report Number: 9616066-2019-00104
• Device Sequence Number: 2154350
• Product Code: FPA
• UDI-Device Identifier: 10885403232596
• UDI-Public: 10885403232596
• 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,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2018

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: 11609481
• Device Catalogue Number: 11609481
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/04/2019; 04/16/2019
• 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, TD (B)(6) 2018
• Patient Age: 3 DA
• Patient Weight: 3