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 Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.(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 the user facility: patient was receiving cancer medication through port with iv- medication - etoposide and nss for flush.The pump rate was set at 238 ml/hr and volume 208 ml.The rate was set higher to accommodate the flush and the medication is given in one (1) hour as ordered.After 30 minutes the bag was found to be infused.The nurse checked the pump, connections and clamp.All seemed to be done correctly.Patient did not have any side effects.Vital signs were within normal limits.The pump was sent to the facility bio med and found to have no discrepancies.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Neither the device involved in the reported incident nor the logs were not returned for evaluation.Without the actual device/logs a thorough investigation could not be performed and further evaluation was not possible.If the device and/or additional pertinent information is received a follow-up report will be filed.Corrected data: report was updated to include the information was received vai medwatch (b)(4).Section report source was updated to include other and medwatch (b)(4).Report was updated to include the device manufacture date of 01/14/2016.
Event or Problem Description
As per the user facility: patient was receiving cancer medication through port with iv- medication - etoposide and nss for flush.The pump rate was set at 238 ml/hr and volume 208 ml.The rate was set higher to accommodate the flush and the medication is given in one (1) hour as ordered.After 30 minutes the bag was found to be infused.The nurse checked the pump, connections and clamp.All seemed to be done correctly.Patient did not have any side effects.Vital signs were within normal limits.The pump was sent to the facility bio med and found to have no discrepancies.Note: this report was received via a medwatch.The medwatch # is (b)(4).

• Brand Name: OUTLOOK®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 7604716
• Report Number: 1641965-2018-00007
• Device Sequence Number: 1396392
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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
• Operator of Device: No Information
• Device Model Number: 621-400ES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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: Other
• Patient Age: 7 YR