MAUDE Adverse Event Report: CANÈ S.P.A. CRONO SUPER PID; AMBULATORY INFUSION PUMP

Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We were made aware by our distributor of an event reported on maude database (report number mw5153640) of which we had not been made previously aware.Event description: "spoke with member's nurse, she did infusion for deferoxamine, and it ran over 8 hours just fine previous day.Today morning, she started the infusion, and pump was infusing too fast, in about 45 minutes, almost less than half of the medication was administered.She stopped the infusion.She asked pharmacy to contact her for assistance.Pharmacist reached out, however she was unable to reprogram the pump herself, arranged for replacement pump to be sent.Member missed half of infusion the day of the occurrence of pump failure, however new one was sent for next day delivery, therefore should not have missed any further doses.No adverse effects reported.Pump would be returned once member receives the return box.At the time of call, no lot number or further pump info available.Indication: hemochromatosis due to repeated red blood cell transfusions.Reported to (b)(6) by: health professional".
Additional Manufacturer Narrative
We were made aware by our distributor of an event reported on maude database (report number mw5153640) of which we had not been made previously aware.Checked conformity of dhr.We asked for further information and for availability of the device: the device was not available for investigation.Should the pump be available in the future, we will reopen the complaint and the report will be updated accordingly.(the submission of this report is past the deadline due to issues with esg webtrader).

• Brand Name: CRONO SUPER PID
• Common Device Name: AMBULATORY INFUSION PUMP
• Manufacturer (Section D): CANÈ S.P.A.; via cuorgnè 42/a; rivoli, 10098 ; IT 10098
• Manufacturer (Section G): CANÈ S.P.A.; via cuorgnè 42/a; rivoli, 10098 ; IT 10098
• Manufacturer Contact: riccardo prudentino ; via cuorgnè 42/a; rivoli, 10098 ; IT 10098
• MDR Report Key: 19939035
• Report Number: 3003098013-2024-00001
• Device Sequence Number: 14684695
• Product Code: FRN
• UDI-Device Identifier: 08050616612021
• UDI-Public: 08050616612021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female