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

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Burning Sensation (2146)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s reported complaint of an over infusion of potassium was not confirmed during the investigation while testing the source device and returned tubing set.Based on the logs, the reported incident occurred between 6:43 pm ¿ 6:54 pm on (b)(6) 2019.An infusion of 100mls of potassium was programmed at a rate of 50ml/h and stopped prematurely after approximately 10 minutes.The total volume infused was recorded at 9.216mls.Test results confirmed the unit passing a timed rate accuracy test utilizing customer¿s returned pcu, the incident programmed parameters and the returned incident administration set.Results demonstrated the device was in specification and operating as intended.Although the silicone segment was found to be marginally out of specification, it was not believed that this contributed to the reported event.The root cause of the customer¿s experience with an over infusion was not definitively identified during the investigation.

Event Description

It was reported that a patient arrived to ed with a cerebral bleed and hypokalemia (2.2mmol/l).The rn initiated a potassium infusion ( 20 meq/100ml) programmed at a rate of 50ml/hr.For 2 hrs., and observed the flow from the drip chamber for a few minutes prior to leaving the patient.Approximately 10 minutes later, the patient complained of burning to his arm and noticed the drug rapidly dripping from the drip chamber.The infusion was quickly stopped, and devices sequestered.

• 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
• 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: 8895387
• MDR Text Key: 154436714
• Report Number: 9616066-2019-02310
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19045580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2019
• 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: 8015, 8100, THERAPY DATE (B)(6) 2019