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

Model Number	10012144
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the set separated between the lower fitment and the safety clamp causing the immune globulin infusion to leak.The rn reported that the tubing was not stretched prior use.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of set separation and leakage was confirmed.During visual inspection it was observed immediately that the silicone segment was completely separated from the lower fitment.The expected retainer ring for the lower fitment and silicone segment connection was not received.Further visual inspection of the separated silicone segment end noted o-ring indentations.On the silicone segment.Dimensional testing was performed on the pumping segment components (upper fitment, o-ring.Silicone and lower fitment).The sample measurements were within specification with no issues noted.The root cause of the failure was not identified.
Event or Problem Description
The customer reported that the set separated between the lower fitment and the safety clamp causing the immune globulin infusion to leak.The rn reported that the tubing was not stretched prior use.There was no report of patient harm.

• 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: 7958098
• Report Number: 9616066-2018-01920
• Device Sequence Number: 13835635
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 10012144
• Device Catalogue Number: 10012144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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: (3) NON-BD ORANGE SWAB CAPS CONNECTED TO SS PORTS.; 8100,8015, TD UNK