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

Model Number	2280-0000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that the tubing set separated from the syringe adaptor.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing separated from the syringe adaptor component was confirmed.Upon inspection, the vented spike component was broken off from the upper fitment assembly of the pump segment.The broken piece was lodged inside of the upper fitment assembly.Magnification of the mating pieces of the broken vented spike showed stress marks on both surfaces which matched up between both surfaces when placed together.Functional testing was not performed because of the obvious damage.The root cause of the broken component was not identified.
Event or Problem Description
The customer reported that the tubing separated from the syringe adaptor component there was no report of patient harm.

• Brand Name: ALARIS® PUMP MODULE SYRINGE ADAPTER SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8001493
• Report Number: 9616066-2018-02006
• Device Sequence Number: 18904402
• Product Code: FPA
• UDI-Device Identifier: 07613203012539
• UDI-Public: 7613203012539
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 2280-0000
• Device Catalogue Number: 2280-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: SYRINGE, THERAPY DATE UNK