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

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product support.Although requested, device has not been received, and patient demographic details were not provided.A follow up report will be submitted with failure investigation results should the device be received for evaluation.(b)(4).

Event Description

It was reported that the user observed that an over infusion of blinatumomab had occurred when the user changed the medication bag.The total volume of bag was 278ml, and the volume to be infused programmed on the pump was 240ml.The patient received an extra volume of medication more than prescriber¿s order.No patient harm occurred as a result of the event.The biomed investigation determined that the pump module tested within specification, and 19 ail alarms had occurred in the logs.A micro crack on the bezel was identified but did not contribute to the event.The user opened the door 8 times to clear the alarm, and entries for ¿flow stop open¿ were observed.During chemotherapy infusions it is expected hospital practice to avoid accessing the line with a syringe.Biomed indicated that during troubleshooting ail, it is believed that more fluid may have flowed than the user expected.

Manufacturer Narrative

Additional event details provided.

Event Description

It was reported that the user observed that an over infusion of a 24 hour primary infusion of blinatumomab had occurred when the user changed the medication bag.The total volume of bag was 278ml, and the volume to be infused programmed on the pump was 240ml; it was expected there would be 38ml left in the bag at the time of the bag change.The tubing priming volume was accounted for.The patient received an extra volume of medication more than prescriber¿s order.No patient harm occurred as a result of the event.The biomed investigation determined that the pump module tested within specification, and 19 ail alarms had occurred in the logs.A micro crack on the bezel was identified but did not contribute to the event.The user opened the door 8 times to clear the alarm, and entries for ¿flow stop open¿ were observed.During chemotherapy infusions it is expected hospital practice to avoid accessing the line with a syringe.Biomed indicated that during troubleshooting ail, it is believed that more fluid may have flowed than the user expected.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8611902
• MDR Text Key: 145110998
• Report Number: 9616066-2019-01364
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2019; 8100,8015, THERAPY DATE (B)(6) 2019