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It was reported that purewick urine collection system had weak suction.Per follow up via phone on 05oct2023, it was reported that the initial purewick urine collection system had no power at all.A replacement device was sent and now the replacement has no suction.Caretaker has performed troubleshooting and the water test failed and stated that the wicks and the patient were saturated with urine.All attachments are plugged in securely and purewick urine collection system was sitting on the floor and new wicks were ordered.When they tried the new wicks, it did not change the suction and issue has not been resolved.Per follow up via phone on 27oct2023, it was reported that purewick urine collection system has completely stopped working.Caregiver stated that purewick urine collection system was defective and stayed on hold for 45 minutes with no response.Customer has sores from sitting in urine due to the device not functioning properly and was prescribed an oral antibiotic to treat the sores.Customer was unhappy that the issue remains unsolved and needs the defective device to be replaced as soon as possible.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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The reported event was confirmed, with the cause unknown.Evaluation of the sample noted: a purewick urine collection system, pump tubing, collector tubing with elbow connector, collection canister with lid, and external power cord were returned.There were no cracks present.There was no residue present.The stop valve was working properly.There was no light or sound with the returned pcba, indicating no function.After attaching the in-house pcba, there was light and sound indicating function.Once the device was opened up, there was a small amount of residue on the base and the rim.Further inside, there was a small amount of residue and corrosion on the returned pcba.There was also a mild amount of pink and opaque white residue in the inner tubing next to the motor.A potential root cause for this failure could be "user does not follow instructions or is unaware that the canister is full" and "inadequate component selection component deterioration".The results of the dhr review did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "intended users: the purewick¿ urine collection system is intended to be operated by: user/patient; caregiver/healthcare professional.All functions can be safely performed by the individuals above.Indications for use: the purewick¿ urine collection system is to be used with purewick¿ external catheters which are intended for non-invasive urine output management.Contraindications for use: do not use the purewick¿ urine collection system with purewick¿ external catheters on individuals with urinary retention.Safety and warnings: always unplug purewick¿ urine collection system before cleaning or when not in use.Do not immerse the purewick¿ urine collection system in water.As with most electrical devices, electrical parts in this system are electrically live even when the power is off.To reduce the risk of electric shock, if the purewick¿ urine collection system falls into water, unplug immediately.Do not reach into the water to retrieve it.Warning: contains small parts that may cause choking.Keep out of reach of children.Keep cords and tubing out of the reach of children to avoid the risk of strangulation.Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas.Warning: this device should not be used in oxygen rich environments or in conjunction with flammable anesthetics.If the purewick¿ urine collection system is dropped or tipped over spilling urine, unplug the unit and carefully inspect for loose or damaged parts before resuming use.The pump tubing connecting the purewick¿ urine collection system to the collection canister may experience light condensation inside the tube.This is not unusual and does not affect function.However, if urine or water has streamed into the pump, discontinue use although the canister can hold up to 2000cc (ml), the urine should be emptied regularly from the collection canister before volume reaches 1800cc (ml).Failure to empty canister before urine overflow may cause damage to the purewick¿ urine collection system and is not covered under the warranty.It is important that the port connections be connected correctly for proper operation of the purewick¿ urine collection system.Use of this equipment next to or stacked with other equipment should be avoided because it could result in improper operation.If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.Portable radio frequency (rf) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30cm) to any part of the purewick¿ urine collection system, including cables specified by the manufacturer.Otherwise, degradation of the performance of this equipment could result.Use only purewick¿ urine collection system accessories with this device.Incompatible parts or accessories can result in degraded performance and will void the warranty.Do not use accessories past expiration date indicated on package labeling.Use only the purewick¿ urine collection system a/c power cord with the device.Use of an alternate consumer style a/c power adapter or an extension cord may cause damage to device and electrical shock or injury and will void the warranty.Do not place purewick¿ urine collection system or its cord across walkways creating a tripping hazard.For pw200: the battery cells used in this device may present a fire or chemical hazard.To minimize the risk of damaging the battery inside the purewick¿ urine collection system, do not use the device outside the indicated operating temperature range of 41°f - 104°f (5°c - 40°c).The battery is not intended to be replaced; replacement could result in a hazard.To reduce the risk of electrical shock or injury, do not disassemble this unit.No modification of this equipment is allowed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the actual/suspected device was inspected.
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It was reported that purewick urine collection system had weak suction.Per follow up via phone on 05oct2023, it was reported that the initial purewick urine collection system had no power at all.A replacement device was sent and now the replacement has no suction.Caretaker has performed troubleshooting and the water test failed and stated that the wicks and the patient were saturated with urine.All attachments are plugged in securely and purewick urine collection system was sitting on the floor and new wicks were ordered.When they tried the new wicks, it did not change the suction and issue has not been resolved.Per follow up via phone on 27oct2023, it was reported that purewick urine collection system has completely stopped working.Caregiver stated that purewick urine collection system was defective and stayed on hold for 45 minutes with no response.Customer has sores from sitting in urine due to the device not functioning properly and was prescribed an oral antibiotic to treat the sores.Customer was unhappy that the issue remains unsolved and needs the defective device to be replaced as soon as possible.
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