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

Model Number	11118122
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 there have been multiple tubing sets found to be separated at various locations.
Event or Problem Description
The customer later confirmed during follow up, that there was no patient involvement associated with this event.
Additional Manufacturer Narrative
The customer¿s report of a separated tubing set was confirmed based on visual inspection.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No other damages or issues were observed.The separation was at the engagement between the silicone segment and lower fitment of the pump chamber assembly.The expected retainer ring for this engagement was not received, however; inspection of the separated silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the silicone segment tubing.No testing was deemed necessary due to the obvious separation.Dimensional analysis was performed and was measured within the required specification.The root cause of the separated tubing set was not identified.

• 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: 9151683
• Report Number: 9616066-2019-02751
• Device Sequence Number: 19506708
• Product Code: FPA
• UDI-Device Identifier: 10885403234675
• UDI-Public: 10885403234675
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 11118122
• Device Catalogue Number: 11118122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1