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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B. BRAUN INFUSOMAT SPACE; PUMP, INFUSION
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B. BRAUN MELSUNGEN AG B. BRAUN INFUSOMAT SPACE; PUMP, INFUSION Back to Search Results
Device Problems Application Program Problem: Dose Calculation Error (1189); Fail-Safe Problem (2936)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Report by staff: "library guardrails did not prevent rapid infusion of potassium (near miss, caught by rn)".Please review this pump, the rn was programming more volume, the rate was increased to over 300 ml per hour.Rn caught this error and video taped the issue.She removed pump from service." report by technician investigating the issue.I have reviewed and was able to duplicate the issue reported by staff.The log shows the risk that iv pump poses for patient care.Staff programmed a pump by choosing kcl 20 from drug library as secondary infusion.The pump was programmed to deliver 50 ml with concentration of 20meq/hour for a duration of 1hour which is equivalent to 50ml/hour.The pump was almost done with the infusion and staff member went in and added vtbi of 5ml (assuming to empty the bag).Iv pump changed concentration and started infusing 311.4 ml/h.Reached out to b.Braun staff and did not get a response from manufacture to what the correction of this problem would be.Fda safety report id# (b)(4).
 
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Brand Name
B. BRAUN INFUSOMAT SPACE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
MDR Report Key13385693
MDR Text Key284802285
Report NumberMW5107040
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention;
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