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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. BBRAUN INFUSOMAT SPACE PUMP LOW ABSORPTION SET SECONDARY IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR
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B.BRAUN MEDICAL INC. BBRAUN INFUSOMAT SPACE PUMP LOW ABSORPTION SET SECONDARY IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 480257
Device Problems Product Quality Problem (1506); Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2022
Event Type  malfunction  
Event Description
Bbraun infusomat space pump low absorption set.Lot # 0061843406 secondary tubing spiked into medication and when nurse went to put tubing into pump to prime, it was seen that tubing was backwards.Iv set that goes into iv pump and clamp were backwards which made it unable to load into iv pump appropriately (from right to left).There is no way to "fix" the tubing, so nurse had to completely switch out tubing.This is the second manufacturer defect found in tubing made by bbraun today.Fda safety report id #(b)(4).
 
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Brand Name
BBRAUN INFUSOMAT SPACE PUMP LOW ABSORPTION SET SECONDARY IV TUBING
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
B.BRAUN MEDICAL INC.
bethlehem PA 18018 3524
MDR Report Key15690534
MDR Text Key302776377
Report NumberMW5112925
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/25/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number480257
Device Catalogue Number480257
Device Lot Number0061843406
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BBRAUN INFUSOMAT SPACE PUMP
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