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

Model Number AX1000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: during priming of micro line 9 (magnesium sulfate) and micro line 13 (5c) bubbles were observed in the tubing.The customer indicated this only occurs when initially priming micro line 9 with magnesium sulfate.Micro line 9 will seep into line 13.No patient involvement.The user replaced the transfer set with no further issues.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used transfer set, with packaging, was returned for evaluation.Visual examination of the transfer set noted no visual defects.The set was vacuum leak tested per specification with passing results.The set was leakage tested per specification with passing results.Additionally, lines 9 and 13 were each pressurized at 10 psi, and the valves were opened and closed.No leakage was noted.The iog review shows at around 10:51am a situation where the solution on valve 9 (mag sulfate) seems to have a lot of bubbles for a particular order.A manifold flush was done and then priming of several ingredients (station 6, station 7 three times, station 8, station 9 five times).This is believed to be when the odd behavior, was noticed which was described as seeping up valve 13.There is no attempt to pump valve 13 after this.There's no evidence of hanging the wrong thing on station 9 or station 13, and no occlusions or excessive bubbles other than during that one order, and the solutions do not seem to run out faster than expected.There is no clear reason why this event occurred.Based on the review of the software logs and a thorough investigation of the transfer set, this particular defect cannot be confirmed.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As per user facility: during priming of micro line 9 (magnesium sulfate) and micro line 13 (5c) bubbles were observed in the tubing.The customer indicated this only occurs when initially priming micro line 9 with magnesium sulfate.Micro line 9 will seep into line 13.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
• MDR Report Key: 7480266
• MDR Text Key: 107570952
• Report Number: 1641965-2018-00006
• 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: 06/29/2018

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 Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1