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

Model Number	AX1000
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The transfer set and the device logs have 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: it was noticed about halfway through the production day that micro line 12 (levocarnitine) was not dispensing fluid.Three (3) bags were scrapped that were possibly pump with an incomplete final container.There was no patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used transfer set was returned for evaluation.Visual examination of the set noted no defects.The set was was occlusion tested per specification with failing results.Line 12 was found to be occluded.A microscopic examination of line 12 indicates an occlusion/obstruction within the tubing joint which appears to be due to excessive solvent applied during assembly.A retained transfer set was visually inspected and no defects were noted.The retained transfer set was occlusion tested and vacuum leak tested per specification with passing results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.The log review confirmed an occurrence of an occlusion error, however the logs show consistent behavior of a source line clog on line 12.The investigation of the returned transfer set also concluded that line 12 did have an occlusion and the device operated as intended.Per the instructions for use (ifu), it is recommended that the user prime each source container until the source container line is full of solution and all bubbles are removed.This may take several primes.It is also recommended that the user use a hand to hold the source solution line and watch and feel for moving fluid through the line.The recommendations from the ifu were provided to the customer.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX
• Common Device Name: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 10545798
• Report Number: 1641965-2020-00018
• Device Sequence Number: 19601487
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/14/2020

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: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1