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

Model Number AX1000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the review of the software logs at exactly 10:43:02 am the compounder attempted to perform several manifold flushes into a waste container but there was no volume or weight being added to the scale with each flush sequence.This indicates that the output line to the waste container was clamped off or restricted causing back pressure into the system.At exactly 11:12:40 am the transfer set was removed, suggesting that fluid was discovered in the empty lines.As per the engineer, the investigation included a review of each prime dispense request and looked at the scale readings.We discovered that the first prime request did not increase the scale weight in relation to the amount of fluid requested to prime.Based on the review of software logs the compounder attempted to perform several manifold flushes into a waste container but there was no volume or weight being added to the scale with each flush sequence.We recommend, prior to attempting to flush into a waste container that the user ensures the outlet tubing is not pinched or obstructed and that the bag clamp is in the open position.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.Manufacturer report numbers 1641965-2017-00046, 1641965-2017-00047, and 1641965-2017-00048 were all reported from the same user facility.

Event Description

As per user facility: fluid was backing up into an empty line on the transfer set during priming.No patient involvement.

• Brand Name: APEX¿
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 7161225
• MDR Text Key: 96452023
• Report Number: 1641965-2017-00048
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1