MAUDE Adverse Event Report: ANGIODYNAMICS INTELLIFLOW; BEDSIDE INFUSION PUMP

Model Number	700102941
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intelliflow pump: an angiodynamics territory manager reported a few "issues." it was, reportedly, hard to tell if the issues were the 25cm talon semiflex probes or a combination of probes and the intelliflow pump, or the rfa unit.The account indicated that water was everywhere but they noticed no holes in the tubing.Ultimately, the procedure was completed with a third probe.There was no harm experienced by the patient; however, the case was delayed over an hour while the patient was under general anesthesia.This event meets the criteria a reportable adverse event; patient safety risk due to prolonged procedure greater than 30 minutes (extended sedation).
Additional Manufacturer Narrative
The intelliflow pump has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).Reference the following for each device used during the procedure: (b)(4) rfa generator 1319211-2023-00063.(b)(4) intelliflow pump 1319211-2023-00064.(b)(4)talon probe 1317056-2023-00135.(b)(4) talon probe 1317056-2023-00139.
Additional Manufacturer Narrative
The customer is not returning the unit for evaluation/service at this time.The unit has been functioning as intended.The reported complaint description is not confirmed because the unit was not returned for service/evaluation.The customer states the unit has been functioning as intended.In addition, one of the probes that was used in this event was returned and was confirmed to be the source of the leak.Disposable device review: two disposable probes were reported for this event and have been evaluated per (b)(4).The probe in (b)(4) was determined to be the cause of the leak.A review of the device history records (service order history) was performed for the reported serial number (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution; i.E.No ncr associated with reported failure mode.Labeling review: the user manual, which is supplied to the user with this unit states "precautions: do not use intelliflow pump or rf generator if either of them has been dropped or damaged.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).(b)(4) rfa generator 1319211-2023-00063.(b)(4) intelliflow pump 1319211-2023-00064.(b)(4) talon probe 1317056-2023-00135.(b)(4) talon probe 1317056-2023-00139.

• Brand Name: INTELLIFLOW
• Common Device Name: BEDSIDE INFUSION PUMP
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17987046
• Report Number: 1319211-2023-00064
• Device Sequence Number: 7259886
• Product Code: GEI
• UDI-Device Identifier: H7877001029410
• UDI-Public: H7877001029410
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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
• Device Model Number: 700102941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown