MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC PROMETRA PATIENT THERAPY CONTROLLER; INFUSION PUMP PROGRAMMER

Model Number	12860
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being evaluated at the manufacturing site.When the investigation is complete, a supplemental report will be filed.Internal complaint number: (b)(4).
Event or Problem Description
It was reported the patient therapy controller (ptc) was inconsistent in bolus delivery, and displayed battery charging issues.There were no patient effects reported, and the device was returned for evaluation.
Additional Manufacturer Narrative
Device evaluation: the device was subjected to external and internal visual inspection, as well as functional and electrical testing.The evaluation determined that the charging issue was caused by an excess resistance on a connector pin of a power cable.Based on the results of the investigation, the reported issues were confirmed.The charging issue was resolved after disconnecting and reconnecting the cable, and the unit operated per specification.An error code indicating that the ptc could not locate and communicate with the pump was observed in the error log several times.The intermittent bolus delivery issue was likely due to attempting to deliver a bolus when the ptc and pump are not within the expected range of each other.Corrected g8 per request of fda, dated 10/sep/2020.Internal complaint number: complaint- (b)(4).

• Brand Name: PROMETRA PATIENT THERAPY CONTROLLER
• Common Device Name: INFUSION PUMP PROGRAMMER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 6157812
• Report Number: 3006803715-2016-00194
• Device Sequence Number: 13547610
• Product Code: LKK
• UDI-Device Identifier: 00810335020174
• UDI-Public: 010081033502017411160616
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

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: Lay User/Patient
• Device Model Number: 12860
• Device Catalogue Number: 12860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1