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

Model Number	2478-0000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
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 when a pump was infusing blood, the saline tubing separated from the top of the filter then the blood leaked out of that hole.There was no patient harm.
Additional Manufacturer Narrative
250ml baxter bag ndc 0338-0049-02 lot number y264705 exp sep 19 0.9% sodium chloride.The customer¿s report of a leak and separation of blood tubing at the top of the filtered drip chamber was confirmed.Visual inspection observed a separation between the top of the blood filter drip chamber where the two tubing lines enter.Closer inspection observed insufficient solvent at the engagement between the tubing and the top drip chamber ports.A dimensional analysis was performed on the pvc tubing; the tubing measured within specification.Due to the tubing being separated no functional testing could be performed.The root cause of the separation is insufficient solvent at the engagement between the tubing and the top drip chamber ports.
Event or Problem Description
The customer reported that when a pump was infusing blood, the saline tubing separated from the top of the filtered drip chamber of the blood tubing, with blood leakage.There was no 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: 8122073
• Report Number: 9616066-2018-02373
• Device Sequence Number: 11073753
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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): 11/07/2018

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 Expiration Date: 08/02/2021
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 18085110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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: 8100, 8015 TD 11/02/2018; SEE H.10
• Patient Weight: 59