The 3.0 liter reservoir involved in the incident was not available for investigation.A review of photographs provided by the user facility indicates evidence of potential residual adhesive in the tubing of the 3.0 liter reservoir, however the photographs are not detailed enough to determine the actual condition of the tubing.Without investigating the set, a root cause cannot be determined.The manufacturing batch records for this lot were reviewed and no related anomalies were identified.A review of past complaints indicates only one other report related to this lot number.All 3.0 liter reservoirs are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.It was reported that the reservoir was replaced; no patient injury was reported.Belmont will continue to monitor, and trend similar reports of this nature, and take further action if required.Should additional information become available, a supplemental report will be provided.
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