BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER
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Catalog Number H938737 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter last name: (b)(6).Two (2) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed, and leak was observed at the administration spike port bonding area for one (1) sample.The reported condition was verified for 1 sample and not verified for the other sample.The cause of the condition could not be determined, however, is most likely due to inadequate or lack for cyclohexanone applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process causing an incorrect bonding.A nonconformance has been opened to address this issue.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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Event Description
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It was reported that two (2) exactamix 250ml eva (ethylene-vinyl acetate) tpn (total parenteral nutrition) bags leaked from the middle connection port.This occurred during visual inspection after the bags were compounded with amino dextrose.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The lot was manufactured between august 10, 2023 and august 11, 2023.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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