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

Model Number 10010454

Device Problems Partial Blockage (1065); Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: fresenius kabi freeflex ; ecoflac plus 500ml bottle,iv bag/bottle, iv flush syringe, unknown manufacturer.Report source - ceo (b)(6).Requested patient demographics however customer declined to answer.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.

Event Description

It was reported that the rn initiated the clinical trial compound c1d1 infusion of 9-ing-41(103 mg/ 520 ml/0.2mg/ml/0.1-1mg/ml) routinely administered over 1hr using a 0.2 filter set.Approximately 30 mins.Into the infusion, the device alarmed for occlusion alarms, patient received 310ml of the total 520ml infusion.The rn flushed the line which was patent and received good blood return.The device was then restarted however the device continued with occlusion alarms.The filter tubing was disconnected after multiple techniques were attempted to fix the occlusion, including changing pump channel, adding 120cc air into collapsed bag and adjusting the connections.The bag and tubing were taken back to pharmacy and tubing was disconnected, wasting approximately 26ml of solution which was destroyed.A new 0.2 micron filter tubing was attached and primed with the trial compound solution.After restarting the infusion, approximately 154ml infused, the device alarmed for occlusion alarms, the infusion was stopped and the remaining unspecified volume was discarded.The event occurred in the oncology clinic.It was later reported that the customer switched to a 1.2 micron in-line filter for the clinical trial without any issues due to a larger filter.There was no report of patient harm.

• Brand Name: ALARIS PUMP MODULE SET
• Type of Device: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8459702
• MDR Text Key: 140172234
• Report Number: 9616066-2019-00869
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: 7613203015806
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10010454
• Device Catalogue Number: 10010454
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (2)8100,8015, THERAPY DATE (B)(6) 2019