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

Model Number	24009-0007T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the tubing silicone segment ballooned at the start of the infusion decitabine via the pump while connected to a patient in the oncology department.The bubble started to become larger as the nurses started the infusion through the infusion pump.There was no harm.
Event or Problem Description
It was reported that the tubing silicone segment ballooned while infusing an decitabine via the pump while connected to a patient in the oncology department.There was no harm.
Additional Manufacturer Narrative
The customer¿s report of balloon in silicone pump segment was confirmed per photo received by the customer.Photo provided by the customer shows a bulge/balloon in the silicone segment tubing near the upper portion of the upper fitment.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.No product will be returned per customer.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8845624
• Report Number: 9616066-2019-02081
• Device Sequence Number: 2088948
• Product Code: FPA
• UDI-Device Identifier: 10885403273827
• UDI-Public: 10885403273827
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 24009-0007T
• Device Catalogue Number: 24009-0007T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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, THERAPY DATE (B)(6) 2019
• Patient Age: 61 YR
• Patient Weight: 81