BAXTER HEALTHCARE CORPORATION CLEARLINK SYSTEM SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2R8401 |
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 11/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that a clearlink system, non-dehp solution set leaked where the drip chamber meets the tubing.This occurred during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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(b)(6).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was received for evaluation.A visual inspection was performed with the naked eye which observed a low assembly at the joint of the tubing and the drip chamber.Functional tests which included pressure, clear passage under water, and priming tests were performed which revealed a leak between the assembly of the tubing into the drip chamber.A dimensional test was performed and the tubing was according to specification.The reported condition was verified.The cause of the condition was unable to be determined.Some potential causes could be an improper manual assembly per a) an improper solvent application b) a low assembly or incomplete insertion of the tubing in the drip chamber, c) damaged component or out of specification, d) interferences between the components.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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Search Alerts/Recalls
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