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

Model Number	621-400ES
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 reported by the user facility: customer stated primary iv solution was set to infuse a total volume of 544 ml at a rate of 362 ml/hr for a total time of 1.5 hours for a full infusion of chemotherapy.No system errors or pump alarms.After 1.5 hours, the remaining volume in the iv bag was 267 ml.The pump under infused the medication and the pump was removed from service.An additional pump was used to administer the remaining dose of iv therapy.No patient harm.Iv solution being infused was camptosar.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc internal report # (b)(4).The reported complaint was not confirmed.Three (3) volumetrics of 362.7 and 544ml tested in specification: 1st test: 531ml or 97% of expected volume.2nd test: 530ml or 97% of expected volume.3rd test: 533ml or 97% of expected volume.Furthermore the pump's operational log was reviewed and there were no indications that the pump malfunctioned.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: 7017179
• Report Number: 1641965-2017-00045
• Device Sequence Number: 19084030
• 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,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR