MAUDE Adverse Event Report: B. BRAUN MEDICAL INC PINNACLE; COMPOUNDER

Model Number	601184
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: customer reported the source pool container is running dry during compounding of bag 6 out of 7 bags.The total volume in the source pool container is 1019.9ml.The programmed volume of the ingredient for each compounded bag is 137ml (150.7g).The volume required in the source pool container to fill the orders is 959ml.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The pump was returned for investigation.A volumetrics sequential run of 111ml for 8 stations concluding with 112ml for the 9th station (total of 1000ml) was performed.The pump tested in specification at 1000ml +/-2.7%.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: PINNACLE
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 10313587
• Report Number: 1641965-2020-00012
• Device Sequence Number: 13700916
• Product Code: NEP
• UDI-Device Identifier: 04046964957437
• UDI-Public: 04046964957437
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 07/09/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1