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

Model Number	11607704
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	11/19/2019
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.White.Additional information is not available.
Event or Problem Description
It was reported that the tubing came apart while hanging a new bag of propofol prior to placing the tubing in the device.This event occurred in the critical care service area, and there was no patient involvement.The tubing had been in use for two days.
Event or Problem Description
It was reported that the tubing came apart while hanging a new bag of propofol, prior to being placed in the device at the time of event.Critical care services.There was no patient involvement.The tubing was in use for (2) days.(received a copy of the customer's medsun report from fda which states, ¿while hanging new bag of propofol infusion and tubing in alans pump, tubing came apart at connection site.Nurse reprimed a new set of tubing, placed in iv pump and infusing without difficulty".).
Additional Manufacturer Narrative
Additional information provided; d.4, & h.6.(device code) the customer's report that the tubing came apart was confirmed.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted separation at the engagement between the primary set's upper fitment and silicone segment components.Examination under magnification of the separated silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the tubing, indicating that it had been properly assembled onto the set.Dimensional analysis of the upper fitment and the silicone segment measured to be within specification(s).No issues of concentricity with the silicone segment were observed.The root cause was not identified.
Additional Manufacturer Narrative
Additional medwatch information provided.
Event or Problem Description
Received a copy of the customer's medsun report from fda which states, ¿while hanging new bag of propofol infusion and tubing m alans pump, tubing came apart at connection site nurse reprimed a new set of tubing, placed m iv pump and infusing without difficulty".

• 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: 9513181
• Report Number: 9616066-2019-03677
• Device Sequence Number: 2217081
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2019

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 Expiration Date: 08/20/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19087420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/13/2020; 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 83