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

Model Number	20029E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient demographics requested however not provided.
Event or Problem Description
It was reported that the filter cracked at an unspecified location and leaked when infusing tpn.The rn noticed the set leaking into the patients bed at the time of the event.A photo received with note on packaging stated: "cracked filter tpn line, leaking on patients bed.Event date (b)(6) at 2100".
Additional Manufacturer Narrative
The customer¿s report of a filter cracked at an unspecified location was not confirmed.Visual inspection of the set noted fluid inside the tubing above the inlet port of the 0.2 micron ped filter.No anomalies or evidence of damage (cracks) were observed.Functional and pressure testing confirmed small droplet leaking from the 0.2 micron ped filter¿s air vent (termed ¿weeping out¿).The root cause of the leak was not identified.
Event or Problem Description
It was reported that the nicu filter cracked at an unspecified location and leaked when infusing tpn.The rn noticed the set leaking into the patients bed at the time of the event.There was no harm caused to the patient from this event and the tubing was changed.A photo received from lab with a note on packaging stated: "cracked filter tpn line, leaking on patients bed event /time''.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8800657
• Report Number: 9616066-2019-01986
• Device Sequence Number: 11516095
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 06/27/2019

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: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 8015,8100,PRI TUBE, THERAPY DATE: (B)(6) 2019.