MAUDE Adverse Event Report: ALGORITHM SCIENCES, INC. PROMETRA II PROGRAMMABLE PUMP; IMPLANTABLE INFUSION PUMP

Model Number	13827
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Nurse from physician's office contacted technical solutions regarding a patient who had experienced a volume discrepancy.The nurse reported that the expected volume was 7ml, but they were unable to aspirate any volume from the pump.The nurse reported that the patient did not show any symptoms associated with the discrepancy.Technical solutions discussed the potential causes of overinfusion volume discrepancies with the nurse.The nurse stated that the physician was not comfortable with refilling the patient's pump at that time.Technical solutions suggested that the physician fill the patient's pump with saline and to bring the patient back in a week to perform a volume check to confirm functionality of the device.Later communication with the nurse confirmed that the physician decided to forgo troubleshooting steps and performed a pump replacement surgery instead.
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed.The review did not identify any non-conformances, issues or capas associated with pump function.Device was not returned for additional evaluation and investigation.As additional investigation was not performed, a definitive root cause could not be determined for the alleged issue.Several follow-up attempts were made with the physician's office to retrieve information regarding device disposition.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Common Device Name: IMPLANTABLE INFUSION PUMP
• Manufacturer (Section D): ALGORITHM SCIENCES, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer (Section G): ALGORITHM SCIENCES, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: nicholas ranalli ; 120 forbes blvd; suite 170; mansfield, MA 02048 ; 8459019335
• MDR Report Key: 17453372
• Report Number: 3010079947-2023-00056
• Device Sequence Number: 7260054
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(17)191217(10)25483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2019
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 25483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female