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

Model Number	C24111E
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that the nurse primed the tubing with an iron sucrose 300mg in normal saline 250ml, placed it into the pump module and it alarmed occlusion immediately.The nurse opened the door and noticed a bulge in the pumping segment.The nurse stated that all clamps were open and there were no iv flushes performed.The tubing was replaced and medication infused on the existing pump module with no further problems.The customer reported that there was no patient harm, delay in care or additional treatment required.
Additional Manufacturer Narrative
The customer report of a balloon in pump segment was confirmed.During visual inspection it was immediately observed that there was a bulge along the silicone segment component directly underneath the upper fitment component.During functional testing it was observed that the silicone segment bulged at the area directly underneath the upper fitment component.Pressure testing confirmed the customer's report.The root cause of the customer's report is unknown.
Event or Problem Description
It was reported that the nurse primed the tubing with an iron sucrose 300mg in normal saline 250ml, placed it into the pump module and it alarmed occlusion immediately.The nurse opened the door and noticed a bulge in the pumping segment.The nurse stated that all clamps were open and there were no iv flushes performed.The tubing was replaced and medication infused on the existing pump module with no further problems.The customer reported that there was no patient harm, delay in care or additional treatment required.

• 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: 8610480
• Report Number: 9616066-2019-01361
• Device Sequence Number: 13998353
• Product Code: FPA
• UDI-Device Identifier: 10885403220937
• UDI-Public: 10885403220937
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/25/2019

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: C24111E
• Device Catalogue Number: C24111E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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, TD (B)(6) 2019; 8100,8015, TD (B)(6) 2019
• Patient Age: 65 YR