MAUDE Adverse Event Report: FIRST BIOMEDICAL INC. DBA INFUSYSTEM CADD-LEGACY PLUS MODEL 6500; PUMP, INFUSION

Model Number 6500

Device Problems Disconnection (1171); Mechanical Problem (1384); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Event Description

Patient on chemotherapy with cetuximab/cisplatin/fluorouracil.Patient presenting to clinic for fluorouracil ambulatory infusion pump disconnect near the end of (b)(6) 2018.Drug was still present in pump reservoir.Dose of 5300 mg=250 ml had been prepared and infusion started approximately 4 days earlier at 2.6 ml/hr to run over 96 hours.Patient only received about 466 mg out of 5300 mg over that time.Pump was running (no alarms), and settings indicated that nearly entire volume had been infused (it had not).Patient did not report anything unusual.Pump had been set up and connected correctly.Cadd-legacy plus pump to be returned to infusystem.Patient will be issued new equipment.Physician notified of incident.Equipment sent fedex express to infusystem.

• Brand Name: CADD-LEGACY PLUS MODEL 6500
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): FIRST BIOMEDICAL INC. DBA INFUSYSTEM; 11130 strang line rd.; lenexa KS 66215
• MDR Report Key: 7693609
• MDR Text Key: 114202311
• Report Number: 7693609
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6500
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA