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

Model Number	621-400ES
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Fall (1848); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (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 reported by the user facility: the pump overinfused a patient's medication.It was stated the nurse hung a 100ml iv bag containing hydromorphone at 2319 and set the rate at 2.5ml/hour and the pump was locked.At 0430 the patient fell out of bed and when the nurse responded the iv bag was empty.The remaining volume on the pump was 89ml.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The pump involved in the reported incident was received for evaluation.A volumetrics run of 2.5ml/hr and 10.2ml (dl: hydromorphone) tested in specification at 10.1ml or 99% of expected volume.Two (2) volumetrics run of 120ml/hr and 10ml tested in specification at 9.90ml and 9.94ml or 99% of expected volume the pump's operational log was reviewed.The og review shows on (b)(6) 2020 at 3:34am (the pump time is 5 hours later than the current time) an infusion start of 2.5ml/hr and 100ml (dl: hydromorphone).At 7:40am a downstream occlusion alarmed with a volume infused to 10.2ml and at 7:51am the pump was put on hold.No further infusions took place.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: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton, tx
• MDR Report Key: 10430108
• Report Number: 1641965-2020-00014
• Device Sequence Number: 19398003
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 621-400ES
• Device Catalogue Number: 621-400ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1