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

Model Number	2429-0500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
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.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that during an infusion using a pump, the silicone segment ballooned.It was unknown if there were any pushes given before, during or after the infusion.There was no patient harm.Although requested, no further information has been received.
Additional Manufacturer Narrative
The customer¿s report of a balloon in the silicone segment was confirmed.Visual inspection of the set noted that the silicone segment tubing had a slight ballooned bulge near the upper portion of the upper fitment.No other anomalies were observed.The set was re-primed with water and the observed bulge segment deflated due to the relief in pressure.Functional and pressure testing resulted in the set flowing freely and ran with no issues with no bulge/balloon in the silicone segment when the device door was opened after infusion was completed.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that during an infusion using a pump, the silicone segment ballooned.It was unknown if there were any pushes given before, during or after the infusion.There was no patient harm.Although requested, no further information has been received.

• 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: 8448720
• Report Number: 9616066-2019-00808
• Device Sequence Number: 14197561
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/26/2019

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: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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: (3)CUROS ALCOHOL DISINFECTANT CAPS; 8015,8100,500ML BAXTER BAG 0.9 % NACL, TD (B)(6) 2019; 8015,8100,500ML BAXTER BAG 0.9 % NACL, TD (B)(6) 2019