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

Model Number AX1000

Device Problems Device Alarm System (1012); Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

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 Description

As per reported by the user facility: while compounding orders it was observed that no solution was being drawn/pumped from tralement (in a syringe on station 13) into the final containers.Station 13 dispensed a total of 17 times prior to the user noticing that solution was not flowing.There was no patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).B.Braun engineering reviewed the logs provided.The log files show occlusion readings that are consistent with the behavior exhibited by a clogged source line on station 13 near the spike.Priming shows that there is a severe occlusion response, but apex does not check for occlusions during priming.Because there is suction pressure built up in source line 13, there is a decreased sensitivity to occlusions because the baseline readings are compromised once the valve is opened.Due to the very small volume dispenses from line 13, coupled with the compromised baseline occlusion readings, apex does not alarm for occlusions, bubbles, or out-of-weight-tolerance issues, and station 13 is able to dispense in what appears to be a clogged state without alerting the user to any issue.One (1) used transfer set was returned for evaluation.Visual examination of the set noted no defects.The returned sample was occlusion tested per specification with passing results.A retained transfer set was also visually examined and no defects were noted.The retained set was occlusion tested per specification with passing results.A review of our discrepancy management system database found no related or similar discrepancies during the production of the batch.Based on the results of the sample evaluation, no specific conclusions can be made regarding the cause of the reported event.The ifu specifies that the user should watch the source line during priming to ensure that fluid is moving through it during the priming.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 11436767
• MDR Text Key: 251166929
• Report Number: 1641965-2021-00006
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 04046955048502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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
• Device Operator: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1