MAUDE Adverse Event Report: CANE S. P. A. CRONO; PUMP, INFUSION

Model Number CRONO PUMP

Device Problems Device Operational Issue (2914); Reset Problem (3019); Torn Material (3024)

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

Event Date 06/25/2018

Event Type  malfunction  

Event Description

Obc placed to pt regarding crono issues.States sn# (b)(4).13 reset itself during the day yesterday and piston retracted back to starting position; states this may have caused the tubing to tug but only noticed that the piston."reset" itself because there was some blood in her tubing.Pt performed the emergency hickman procedure on herself to ensure there wasn't any clots in her tubing.She restarted infusion using her backup pump and states she forgot to call for a replacement pump.Advised author will send out replacement crono pump and have team f/u during business hours for extra supplies.Pt (b)(6).Programmed crono pump sn# (b)(4).15 (due 06/19/2019) to rate 380micro/hr.Dose or amount: 97ng/kg/min, frequency: q48hours, route: iv.Dates of use: from (b)(6) 2011 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: CRONO
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CANE S. P. A.
• MDR Report Key: 7654523
• MDR Text Key: 113162174
• Report Number: MW5078190
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CRONO PUMP
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR