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Root cause: a root cause cannot be identified at this time.Deroyal has not been provided adequate information in order to complete an investigation.The end user of the device did not report this incident to deroyal.Deroyal was only made aware of this incident by the fda who received the report through the medwatch program.Deroyal reached out to the fda but were unable to attain additional information beyond what was reported through the sus voluntary event report.At this time, deroyal cannot obtain more information.The sus voluntary event report stated the following: "the deroyal prospera npwt malfunctioned over the weekend with a patient.Two dressings (using the gauze style packing) connected to a single pump, set to continuous -150 mmhg.At some point the pump quite registering -150 mmhg and did not alarm.The canister became full and did not alarm.One of the dressings lost a seal completely and no alarm due to loss of seal.The wound bed is now pale, very macerated.The other wound (both of these are very deep post op wounds) still looks red, granulating.The other wound dressing held its seal.This is the most recent in a number of issues we have experiences with this npwt device." deroyal initiated an internal corrective action item (capa) to investigate several areas to determine possible actions necessary.The first action was to: 1) determine applicable complaint reports.A review of internal complaint reports was conducted from 1/1/2013-5/6/2018.Npwt - pump complaints 1_1_2013-5_7_2018_jmc_as.The findings from this investigation did not yield any direct similarities between previous reported complaints and this incident.The review was completed on 5/6/2018 and documented in (b)(4).2) a review of current product instructions for use was conducted.A review of the user manual was conducted for the deroyal pro-ii and pro-iii pumps by (b)(6) (regulatory affairs specialist) by 6/25/2018.The findings from this review yielded that our instructions for use do not indicate or state that a single unit may be hooked up to multiple wounds at the same time.In addition to this, it is considered best practice to not attach multiple wounds to the same device, and it is the healthcare provider's responsibility to correctly evaluate and identify when it may be acceptable to do this.3) an evaluation of patient and healthcare professional involvement was conducted.A review of the sus voluntary event report was conducted by (b)(6) (regulatory affairs specialist) before 6/25/2018 and yielded the following findings: i) the "pump malfunction", as described by the event reporter, took place "over the weekend" indicating the patient may not have been monitored appropriately.Ii) it was reported the "pump quite registering -150 mmhg and did not alarm", however, one of the dressings "did not lose its seal" and "still looks red, granulating".This would indicate the pump, in this capacity, was functioning as designed, maintaining pressure, and therefor would not alarm.It is the responsibility of the healthcare provider to provide proper care through use of the device and indicates user error played a role in this incidence.Iii) the "canister became full and did not alarm", as described the by event reporter, is not logically congruent with the other complaints listed in the report.In the event of a full canister, the pump will no longer be capable of maintaining pressure at the wound bed, however, the event report states "the other wound dressing held its seal".This would indicate potential user error.4) and, determine if the root cause is the result of misuse of device (if misuse is determined, no further action required).Corrective action was not taken and determined not to be required due to the root cause determination and potential of end user misuse of the device.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
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Deroyal industries, inc.Was made aware of a sus voluntary event report by the fda through the medwatch program on november 7th, 2017.(report #: mw5073088).The report stated the following: the deroyal prospera npwt malfunctioned over the weekend with a patient.Two dressings (using the gauze style packing) connected to a single pump, set to continuous -150 mmhg.At some point the pump quite registering -150 mmhg and did not alarm.The canister became full and did not alarm.One of the dressings lost a seal completely and no alarm due to loss of seal.The wound bed is now pale, very macerated.The other wound (both of these are very deep post op wounds) still looks red, granulating.The other wound dressing held its seal.This is the most recent in a number of issues we have experiences with this npwt device.
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