MAUDE Adverse Event Report: B. BRAUN MEDICAL INC OUTLOOK®; INFUSION PUMP

Model Number	621-400ES
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
As per user facility: nurse ran an infusion of magnesium (unknown manufacturer) in a 500ml bag (unknown manufacturer).The nurse programmed magnesium as maintenance rate (2g) 50ml/hr and then programmed the loading dose (4g) 200ml/hr over 30 minutes.After 30 minutes the pump is to automatically bump the infusion back to the loading dose of (2g) 50ml/hr.It did not and the patient received the loading dose (4g) 200ml/hr for an additional half hour before the nurse recognized the dose being run at (4g).The patient received a total of 1 hour infusion of 4 grams magnesium.The nurse immediately stopped the infusion at the time she recognized the patient had an over infusion.The incident was reported to the physician on (b)(6) 2018.The physician ordered calcium gluconate as an antidote and vitals to be monitored and labs were ordered.The nurse also reported the incident to the nurse manager.No patient identifiers were given and the pump was sequestered to the facility's biomed.The patient had no ill effects from the event.
Event or Problem Description
As per user facility: nurse ran an infusion of magnesium (unknown manufacturer) in a 500ml bag (unknown manufacturer).The nurse programmed magnesium as maintenance rate (2g) 50ml/hr and then programmed the loading dose (4g) 200ml/hr over 30 minutes.After 30 minutes the pump is to automatically bump the infusion back to the loading dose of (2g) 50ml/hr.It did not and the patient received the loading dose (4g) 200ml/hr for an additional half hour before the nurse recognized the dose being run at (4g).The patient received a total of 1 hour infusion of 4 grams magnesium.The nurse immediately stopped the infusion at the time she recognized the patient had an over infusion.The incident was reported to the physician on (b)(6) 2018.The physician ordered calcium gluconate as an antidote and vitals to be monitored and labs were ordered.The nurse also reported the incident to the nurse manager.No patient identifiers were given and the pump was sequestered to the facility's biomed.The patient had no ill effects from the event.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.(b)(4).The volumetric accuracy was tested at 200ml/hr and 435.8ml and the pump tested in specification at 428ml, or 98% of expected volume.Furthermore, the log review shows on (b)(6) 2018 at 14:25pm an infusion start of 200ml/hr and 495.2ml (dl: magnesium sulf) with rate guard override.At 14:51 pm a downstream occlusion stopped the infusion with a volume infused to 85.3ml.At 14:53pm an infusion start of 200ml/hr with rate guard override.At 16:58pm the infusion was stopped with a volume infused to 435.8ml.Note: magnesium sulf is not configured for loading dose.Based on the results of the investigation, the pump operated as intended.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: OUTLOOK®
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 7236649
• Report Number: 1641965-2018-00002
• Device Sequence Number: 1014580
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/02/2014
• Device Model Number: 621-400ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention