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

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s experience of an over infusion was neither confirmed nor replicated.¿the pcu event log contained no obvious programming errors that would result in the reported event.The log review indicates that the user set the vtbi to 50 mls and the device delivered the vtbi then alarmed for ¿infusion complete ¿ kvo¿ and was shut off.¿functional testing performed found the pump module to be delivering fluid within specification.¿there were no anomalies observed with the returned primary set (model 2420-0007) and there were no leaks observed from the set.¿the disposable set (model 2420-0007) was evaluated and was found to be slightly out of specification (0.001, and 0.002") however testing could not replicate the reported over infusion condition, therefore this is not believed to have contributed to the reported event.The starting/ending volume of the fluid container cannot be determined through device logs.

Event Description

Received a copy of the customer's medwatch report from fda which states, ¿amiodarone drip hung at 16.67ml/hr.Forty five (45) minutes later, entire 200ml bag was empty.Amiodarone 360mg in 200ccd5w - 0.5mg/min."although requested, no further details were provided by the customer for this event.

Manufacturer Narrative

The customer¿s experience of an overinfusion was neither confirmed nor replicated.The pcu event log contained no obvious programming errors that would result in the reported event.The log review indicates that the user set the vtbi to 50 mls and the device delivered the vtbi then alarmed for ¿infusion complete ¿ kvo¿ and was shut off.Functional testing performed found the pump module to be delivering fluid within specification.There were no anomalies observed with the returned primary set (model 2420-0007) and there were no leaks observed from the set.The disposable set (model 2420-0007) was evaluated and was found to be slightly out of specification (0.001, and 0.002") however testing could not replicate the reported over infusion condition, therefore this is not believed to have contributed to the reported event.The starting/ending volume of the fluid container cannot be determined through device logs.

Event Description

Received a copy of the customer's medwatch report from fda which states, ¿amiodarone drip hung at 16.67ml/hr.Forty five (45) minutes later, entire 200ml bag was empty.Amiodarone 360mg in 200ccd5w - 0.5mg/min."although requested, no further details were provided by the customer for this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 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: 9056708
• MDR Text Key: 158618629
• Report Number: 9616066-2019-02603
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19056776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2019
• 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: 8015,3 CUROS CAP,THERAPY DATE (B)(6) 2019
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG