MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PINNACLE; SYSTEM/DEVICE, PHARMACY CO

Model Number	601184
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number: (b)(4).The device involved has not been received for evaluation, and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As per reported by the user facility: patient final containers are running out early (1 to 1.5 hours) using a curlin iv pump.It is reported that the pinnacle pump module is going into the compounding complete screen without alarming.This issue is only occurring with total parental nutrition (tpn) bags with large volumes.No injuries were reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was received for evaluation.A volumetrics sequential run of 111ml for 8 stations concluding with 112ml for station 9 (total volume 1000ml) tested in specification at 1000ml +/- 2.7% with no errors.Based on the results of the investigation, the pump operated as intended.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Common Device Name: SYSTEM/DEVICE, PHARMACY CO
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 10874532
• Report Number: 1641965-2020-00022
• Device Sequence Number: 16859740
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: (01)04046964957437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 601184
• Device Catalogue Number: 601184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1