BAXTER HEALTHCARE CORPORATION I.V. SOLUTION ADMINISTRATION SETS WITH STOPCOCKS; SET, BLOOD TRANSFUSION
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Catalog Number MMC2081B |
Device Problems
Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name, address, phone: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a theatre administration set for blood and blood components would not flow due to a piece of plastic that blocked the 3-way tap.It was further reported that the piece of plastic ¿was too big to pass through the tap and go towards the patient but it was big enough to occlude the port and damage it¿.The reporter stated that "they could not inject drugs and once the piece of plastic was removed, fluids were observed dripping from the tap".This was observed during priming before being connected to a patient.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation. visual inspection was performed to the photograph using the naked eye which revealed a piece of plastic by the stopcock.The reported condition was verified. by the nature of the sample, no additional tests were performed. the cause of the condition could not be determined. a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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