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Adverse Event Report

B. BRAUN MEDICAL, INC. SECONDARY PIGGYBACK TUBING (SECONDARY IV SET) SECONDARY PIGGYBACK TUBING FOR USE WITH HORIZON NXT PUMP   back to search results
Model Number REF V1921
Event Description

The tubing would not prime even with correct procedure being followed (with the primary iv fluids below the piggyback), the piggyback would never infuse when programmed through the pump. Any piggyback mixed in a glass bottle would not infuse. If the nurse did not have time to "babysit" her piggyback, it would result in a missed or late dose. The spike on the tubing was too long, resulting in only half the dose infusing if it was mixed in a small amt (50 cc's). Many times the piggyback would back into the primary fluids. This was most obvous when the piggyback fluid was a different collor than the clear primary fluids.

 
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Brand NameSECONDARY PIGGYBACK TUBING (SECONDARY IV SET)
Type of DeviceSECONDARY PIGGYBACK TUBING FOR USE WITH HORIZON NXT PUMP
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
824 twelfth avenue
p.o. box 4027
bethlehem PA 18018
Device Event Key502917
MDR Report Key513907
Event Key487591
Report NumberMW1031263
Device Sequence Number1
Product CodeFPA
Report Source Voluntary
Report Date 02/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/01/2008
Device MODEL NumberREF V1921
Device LOT Number060520391
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/11/2004
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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