MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX¿; SYSTEM/DEVICE, PHARMACY CO

Model Number AX1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (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 reported by the user facility: infusion bags are running dry early when administered to patients.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The device involved and the logs were not provided for evaluation.The customer did provide compounding activity reports (cars) for review.Per review of the cars by b.Braun's engineering the bags were compounded within specifications.With both a volumetric delivery and gravimetric check, the volumes and percent variance reported on the apex car are what b.Braun stands by.Both the pump and load cell are calibrated with every new transfer set as well.This being the case, we still will occasionally field reports like this from pharmacies and their patients.A critical variable in the administration accuracy is the programming of the infusion pump itself.No information was provided to b.Braun regarding the infusion pump(s) used to administer the bags to the patient(s).The customer was provided with information if they are concerned the problem is the load cell calibration or the calibration mass itself.Apex allows for a +/-6% variation for the mass readings, so if the 2kg was not exactly 2kg, this could throw off some of the calibration of the volumetric pumping as well as the gravimetric checking that is performed by apex.Apex supports an optional "load cell verification" workflow, where customers can program in different masses to have apex measure to ensure that the main load cell calibration of the 2kg weight is consistent with the measurement of other masses.The customer will need one of those load cell verification platforms to do this.The customer was also instructed they could try weighing the 2 kg mass on a calibrated scale they have access to in order to confirm it is about 2000 grams still (deviations of less than +/- 20grams would not be a cause for concern).They could also request a new 2 kg mass from b.Braun.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX¿
• Type of Device: SYSTEM/DEVICE, PHARMACY CO
• 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: 12613800
• MDR Text Key: 277188182
• Report Number: 2523676-2021-00357
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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
• Date Manufacturer Received: 09/28/2021
• 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