MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problems Break (1069); Contamination (1120); Crack (1135); Display Difficult to Read (1181); Excess Flow or Over-Infusion (1311); Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2023

Event Type  malfunction  

Event Description

It was reported that an infusion of potassium phosphate (250ml) was programmed to infuse at a rate of 64.2 ml/hr however the infusion was completed in approximately in 30 minutes.Customer is requesting an inspection of the devices.Received a copy of the customer's medwatch report from fda which states, "med ordered to be given post renal lab results.Infusion was started at 1733 infusion information sent to iv channel from the computer in patient room.Information was double checked by rn.Rate ordered 64.2 ml/hour to infuse over 4 hours came in 250 ml ivpb.Infusion was started as normal 64.2 ml/hour as shown in mar.At 1800 during hourly rounding potassium bag was empty noticed by rn.Channel still had 64.2 rate on it and was lit up green indicating no issues.Channel never alerted to any issues.No liquids on the floor or on patient.Channel showed volume infused to be 32.3 ml when checked by rn.Mar recorded 37.66 ml out of 250 that bag had.Chart indicates rate that was set to run was 64.2 ml/hr." through due diligence follow up attempts, it was confirmed by the customer there was no patient harm.

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

Manufacturer Narrative

Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

Event Description

It was reported that an infusion of potassium phosphate (250ml) was programmed to infuse at a rate of 64.2 ml/hr however the infusion was completed in approximately in 30 minutes.Customer is requesting an inspection of the devices.Received a copy of the customer's medwatch report from fda which states, "med ordered to be given post renal lab results.Infusion was started at 1733 infusion information sent to iv channel from the computer in patient room.Information was double checked by rn.Rate ordered 64.2 ml/hour to infuse over 4 hours came in 250 ml ivpb.Infusion was started as normal 64.2 ml/hour as shown in mar.At 1800 during hourly rounding potassium bag was empty noticed by rn.Channel still had 64.2 rate on it and was lit up green indicating no issues.Channel never alerted to any issues.No liquids on the floor or on patient.Channel showed volume infused to be 32.3 ml when checked by rn.Mar recorded 37.66 ml out of 250 that bag had.Chart indicates rate that was set to run was 64.2 ml/hr." through due diligence follow up attempts, it was confirmed by the customer there was no patient harm.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, 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: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16814588
• MDR Text Key: 313999296
• Report Number: 2016493-2023-153757
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810046
• UDI-Public: (01)10885403810046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 138 KG