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 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).This particular complaint cannot be confirmed for valve misalignment because the transfer set was not returned and the software logs were not retrieved or provided at the time the event occurred.As a result, no conclusions can be derived or provided.It is known that if the transfer set is removed after the leak check test has been performed, macro valve #1 will be slightly skewed as this occurs so the user can remove the transfer set if need be.Review of the discrepancy management system (dsms) database performed for the reported transfer set lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: customer reported a leak check failure.Upon inspection of the transfer set it was noticed that the line 1 valve was skewed.No patient involvement.The user replaced the transfer set with no further issues.

• 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: 7713355
• MDR Text Key: 114806638
• Report Number: 1641965-2018-00014
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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
• Date Manufacturer Received: 06/29/2018
• 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