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

Model Number AX1000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

(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 Description

As per user facility: during priming of the lines during initial setup, it was visually confirmed that water is traveling up the lines from the transfer set manifold towards the source containers on stations 22 and 23.No patient involvement.The user replaced the transfer set with no further issues.

Event Description

As per user facility: during priming of the lines during initial setup, it was visually confirmed that water is traveling up the lines from the transfer set manifold towards the source containers on stations 22 and 23.No patient involvement.The user replaced the transfer set with no further issues.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual apex compounding system was not returned for evaluation; however, the pump logs and the transfer set that was used with the apex compounding system were returned.One (1) used set without packaging was returned for evaluation.Visual examination of the set noted no visual defects.The set was vacuum leak tested per specification with passing results.The set was leakage tested per specification with passing results.In review of the logs, it was observed during the first prime and flush after the transfer set is installed, 144ml is dispensed from station 1 but the scale reading does not increase.For comparison, during the first prime after a new transfer set is installed, the scale reading starts increasing within 10 seconds.This is due to either a clamped waste bag or an obstruction in the final container line that may have been pinched during installation of the transfer set.The user needs to pay particular attention when installing the transfer set to ensure the final container line is laying properly in the exit channel prior to door closure, or that the waste container bag is not clamped prior to priming and flushing the set.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: 7450412
• MDR Text Key: 106970945
• Report Number: 1641965-2018-00004
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 04/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1