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

Catalog Number AX1000

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device logs have been received.The transfer set has not been returned for evaluation at this time.The investigation is currently ongoing.A follow-up will be submitted when the investigation results become available.

Event Description

As per user facility: customer reported the leak check was failing.Customer indicated the valves on port m1 and m2 are skewed.No patient involvement.

Event Description

As per user facility: customer reported the leak check was failing.Customer indicated the valves on port m1 and m2 are skewed.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device logs were received.The log review did not confirm an occurrence of a leak check failed.One (1) used transfer set with packaging was returned for evaluation.Visual examination of the set noted no visual defects.The set was vacuum leak tested with passing results.Visual examination of a retained unit noted no visual defects.The retained unit was vacuum leak tested and occlusion tested per specification with passing results.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.Upon further review of the complaint and the information provided by the customer it was determined the valves of the transfer set were not misaligned.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: 8770937
• MDR Text Key: 151736825
• Report Number: 1641965-2019-00012
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: 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: 08/28/2019

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 Catalogue Number: AX1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2019
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1