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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXA/ BAXTER HEALTHCARE CORPORATION BAXA RAPID FILL
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BAXA/ BAXTER HEALTHCARE CORPORATION BAXA RAPID FILL Back to Search Results
Model Number RAPID FILL
Device Problems Air Leak (1008); Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2015
Event Type  malfunction  
Event Description
Baxa rapid fill under-filled syringes on programmed volume.Syringe was under-filled due to air pulled into the syringe.Instrument did not alarm error.
 
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Brand Name
BAXA RAPID FILL
Type of Device
BAXA RAPID FILL
Manufacturer (Section D)
BAXA/ BAXTER HEALTHCARE CORPORATION
MDR Report Key4898952
MDR Text Key6537438
Report NumberMW5043692
Device Sequence Number1
Product Code LHI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2015
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRAPID FILL
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FENWAL SODIUM CITRATE 4% 500ML
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