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

Model Number	CRONO SUPER PID
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Anemia (1706); Headache (1880); Nausea (1970); Abdominal Cramps (2543)
Date of Event	02/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were made aware by our distributor of an event reported on maude database (report number mw5100144) of which we had not been made previously aware.Checked conformity of dhr.We asked for further information and for availability of the device: based on the information received, a possible cause is wrong programming of the flowrate by the patient.Once the pump is returned the inspection will be completed and the report will be updated accordingly.
Event or Problem Description
We were made aware by our distributor of an event reported on maude database (report number mw5100144) of which we had not been made previously aware.Event description: "spoke with patient regarding issues with deferral and crone pump, she advised yesterday she thought battery was low so she took out batteries and put them back in.She noticed during her scheduled infusion that it started beeping and infusion was completed after only 30 minutes instead of usual 8 hours.She reached out to her nurse and was advised to seek medical attention since she reported side effects of heart palpitations.She called on-call md for hematology and they advised she should be okay.She went to md and some blood work and had low hemoglobin.Scheduled to receive a blood transfusion for this tomorrow.She said earlier that she did have the heart palpations, headache, nausea and stomach cramps.She advised she is no longer experiencing these side effects.Following up with md and nursing tomorrow.Reported to (b)(6) by: patient/caregiver.".

• 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
• MDR Report Key: 11876729
• Report Number: 3003098013-2021-00001
• Device Sequence Number: 3410943
• Product Code: FRN
• UDI-Device Identifier: 08050616612021
• UDI-Public: 08050616612021
• Combination Product (Y/N): N
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CRONO SUPER PID
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR