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

Model Number AX1000

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device logs have been returned for evaluation.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: customer reported the calibration was failing.Upon inspection of the transfer set it was noticed that the line 2 valve was slightly skewed.The transfer set was not checked prior to using.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).Apex technical support was able to confirm the issue of occlusions.The log review did not confirm any events for pump calibration failure.One (1) used set, without packaging, was returned for evaluation.Visual examination of the set noted no visual defects.The set was occlusion tested on line 1 with passing results.Visual examination of a retained transfer set noted no visual defects.The retained unit was occlusion tested 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 investigation this complaint is not confirmed for valve misalignment.B.Braun will continue to investigate, trend, and monitor all complaints of this nature.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: customer reported the calibration was failing.Upon inspection of the transfer set it was noticed that the line 2 valve was slightly skewed.The transfer set was not checked prior to using.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
• MDR Report Key: 7751300
• MDR Text Key: 116048230
• Report Number: 1641965-2018-00018
• 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: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 07/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1