BAXTER HEALTHCARE CORPORATION CLEARLINK SYSTEM SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2R8401 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that a clearlink system solution set leaked from the tubing.There was a cut/slice in the soft tubing.This was observed prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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B3: event date: the event occurred on an unspecified date of (b)(6) 2024.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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Additional information was added to d4, d9, h3, h4, h6, and h10: h10: the device was received for evaluation.Visual inspection of the device identified a cut/hole in the tubing.Visual inspection of the slide clamp did not identify any defects that could have contributed to the reported condition.Pressure and clear passage under water testing were performed on the sample, and a leak was observed in the tubing.Functional slide clamp testing (under water pressure and clamp activation) was performed with no issues noted.Dimensional testing on the tubing was performed and no observed issues.The reported condition was verified.The probable cause was due to improper handling of the tubing during the manufacturing process.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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