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

Model Number	10015862
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
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 not sequestered for failure investigation.The root cause of this failure was not identified.Additional patient information: (b)(6).Other relevant history: breast cancer.
Event or Problem Description
It was reported that as the carboplatin infusion (secondary set) was finishing, the bag emptied and the last of the drug entered the drip chamber.The drip chamber collapsed and the bag was sucked completely dry.The pump module started to alarm and would not infuse any more drug with message "empty container/fluid side".An attempt was made to infuse the remainder of the chemotherapy by gravity, but the peripheral iv back flowed due to suction/pressure in the line and the chemotherapy did not infuse.It was as if the tubing needed to be vented, but the secondary set did not have a vent.Per pharmacy, the priming volume of the set is less than 5% of patient's total volume dose and therefore per pharmacy, it was ok to waste remaining chemo in tubing and proceed with flush of primary line.The primary line flushed without incident.20ml of the medication was wasted, and it was reported as under infusion.

• 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: 8879038
• Report Number: 9616066-2019-02271
• Device Sequence Number: 227548
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: 10885403221866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 10015862
• Device Catalogue Number: 10015862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• 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: 2426-0007, 8015, 8100, THERAPY DATE (B)(6) 2019
• Patient Age: 59 YR
• Patient Weight: 100