Model Number QS89161000 |
Device Problems
Crack (1135); Leak/Splash (1354); Pumping Problem (3016)
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Patient Problem
No Information (3190)
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Event Date 09/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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Event Description
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According to the available information, pump leaked and tubing was cracked.
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Manufacturer Narrative
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This follow-up mdr is created to document the additional event information and conclusion of the investigation.The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
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Event Description
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Additional information to clarify the reported event - the pump failed.Leak and cracked tubing were reported.The device was removed.
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Manufacturer Narrative
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The follow-up was created to document the conclusion of the investigation.A titan pump and two cylinders were received for evaluation.Examination and testing of the components revealed a separation in the exhaust tubing of cylinder 2, near the strain relief.Testing revealed this to be a site of leakage.Microscopic examination revealed the surfaces to be rough and irregular, indicating stress was exerted.Partial separations within abrasion were noted on the exhaust tubing of cylinder 2, the longer exhaust tube of the pump and inlet tube of the pump.Testing revealed these to not be sites of leakage.No functional abnormalities were noted with the pump or cylinder 1.Based on recreation of the position of the pump tubes according to the abrasion pattern, this demonstrates that the longer exhaust tubing and inlet tubing were overlapping each other.This positioning, in combination with device usage over time, could contribute to sufficient stress on the exhaust tube of cylinder 2 to result in a separation through the exhaust tubing near the strain relief of cylinder 2.A separation of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no non-conformances for this lot.No capas are associated with this lot.
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Search Alerts/Recalls
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