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

Model Number	11590100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/19/2019
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 iv tubing was being used in neonatal intensive care unit (nicu) and the bottom part of the tubing, where two clear plastics meet, broke apart.The nurse tried to put it back together but unable to do so.
Additional Manufacturer Narrative
The customer report that the tubing came apart was confirmed.The separation was at the engagement between the upper fitment and silicone segment components.The expected retainer ring at the upper fitment component area was not received for investigation.No obvious damages or issues were observed with the upper fitment component.No functional testing was deemed necessary due to the obvious separation.Visual inspection under magnification of the separated silicone segment end identified no evidence of a retainer ring indentation.A slight tug/pull of the silicone segment away from the lower fitment component was attempted and no separation was observed.The root cause was identified as due to a misassembly of the set's retainer ring not being assembled onto the set during its manufacturing process.
Event or Problem Description
It was reported that the iv tubing was being used in neonatal intensive care unit (nicu) and the bottom part of the tubing, "where two clear plastics meet," broke apart.The nurse tried to put it back together but unable to do so.Although requested, there was no information provided regarding any intervention rendered to the patient.

• 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: 9038918
• Report Number: 9616066-2019-02574
• Device Sequence Number: 2192412
• Product Code: FPA
• UDI-Device Identifier: 10885403232411
• UDI-Public: 10885403232411
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 08/20/2019

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: 04/30/2022
• Device Model Number: 11590100
• Device Catalogue Number: 11590100
• Device Lot Number: 19047009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 09/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1