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

Model Number	2429-0500
Medical Device Problem Codes	Failure to Disconnect (2541); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	12/31/2019
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.
Event or Problem Description
It was reported that during a code blue the tubing would not unclamp in the (lvp) channel.The pump alarmed occlusion, the tubing was changed and the pump worked immediately.This event occurred at the patient's bedside, the medication/fluid in the tubing is unknown and caused a delay in treatment since iv tubing had to be changed.
Additional Manufacturer Narrative
The customer¿s report that the tubing would not unclamp in the pump channel was not confirmed.Further testing of activating the set's lower fitment safety clamp while loaded in a pump module observed no issue.The set sample was inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.The set was re-primed and the fluid flowed through and exited the set as expected.A lab gauge needle was attached to the set's exit and the set was loaded into a lab pump module.An infusion was programmed and the infusion completed as expected with no alarm or issue.The root cause was not identified.
Event or Problem Description
It was reported that during a code blue the tubing would not unclamp in the (lvp) channel; "during set-up per intake form".The pump alarmed occlusion, the tubing was changed and the pump worked immediately.This event occurred at the patient's bedside.The medication/fluid in the tubing is unknown, and although this caused a delay in treatment to change the iv tubing, it was further confirmed that there was no patient harm or impact associated with this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9597664
• Report Number: 9616066-2020-00189
• Device Sequence Number: 19457907
• 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): 01/02/2020

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: 01/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/10/2020
• 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,THERAPY DATE UNKNOWN