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

Model Number	10879047
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, ndc (b)(4), lot number y274399, exp (b)(6), potassium chloride and 10ml bd syringe, ref (b)(4), lot number 8141801, exp (b)(6) 2021, 0.9% sodium chloride.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that the iv tubing set developed a balloon in the pumping segment while inserted in the pump module and infusing iv fluids which caused the pump to alarm that there was an error.There was no iv push performed prior to the event of the balloon occurring in the silicone pumping segment.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of a balloon in the pumping segment was not confirmed.Visual inspection found no instances of ballooning and functional testing did not replicate any pump alarms or balloon segments.The root cause of the customer¿s report could not be identified.
Event or Problem Description
The customer reported that the iv tubing set developed a balloon in the pumping segment while inserted in the pump module and infusing iv fluids which caused the pump to alarm that there was an error.There was no iv push performed prior to the event of the balloon occurring in the silicone pumping segment.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: 8060893
• Report Number: 9616066-2018-02195
• Device Sequence Number: 11482861
• Product Code: FPA
• UDI-Device Identifier: 10885403232275
• UDI-Public: 10885403232275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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 Expiration Date: 10/31/2020
• Device Model Number: 10879047
• Device Catalogue Number: 10879047
• Device Lot Number: 17107953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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, THERAPY DATE (B)(6) 2018