MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERFUSOR®; PUMP, INFUSION

Catalog Number 8713030

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)

Patient Problems Toxicity (2333); No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report (b)(4).The device has been requested to send it for investigation to bbm laboratory in (b)(4).In the moment the device is investigate in our service laboratory.If we get new information, an investigation report will create.This report is being filed for pump 8713030, serial number: (b)(4), however there were four (4) other infusion pumps in use on the patient at the time the adverse event occurred.An adverse event report has been filed for each of the pumps in use at the time of the event; the other report numbers are 9610825-2019-00371, 9610825-2019-00372, 9610825-2019-00373, and 9610825-2019-00374.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): "wrong rate".Customer information: patient had to be resuscitated due to potassium intoxication.Staff assume a wrong rate due to an incorrectly programmed infusion rate or other manipulation.Customer want an investigation of the infusion pump.

Manufacturer Narrative

(b)(4) (importer) is submitting this report on behalf of b.Braun melsungen ag(manufacturer).This report has been identified as b.Braun melsungen ag internal report (b)(4).During the analysis of the history log files it could be found that the device on the day of occurence was used.No abnormalities could be found.During the visual inspection of the perfusor space, all cover caps on the screw pillars and the seal on the lower housing were available and undamaged.It was possible to detected some age related signs of wear and tear.The functional test was performed.The device passed the self test with a positive result.A syringe could be successfully identified and selected in the pump menu.It was possible to bring the pump in operation.The delivery accuracy of the pump was checked (rate 5ml/h).The determined value (+0,33%) was within specification (+-2%) (according to en iso 60601-2-24).For an inside investigation the device was disassembled.The inside of the device was slightly dirty, but no damages could be found the complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by (b)(4).

• Brand Name: PERFUSOR®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen,
• MDR Report Key: 8907915
• MDR Text Key: 154794320
• Report Number: 9610825-2019-00370
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8713030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention