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The reported event was confirmed, cause unknown.The potential causes of the failure are inadequate component (material) selection/ inadequate component selection/component deterioration/ user does not follow instructions.Visual evaluation of the returned sample noticed one opened (without original packaging) pw collection system with accessories (pump tubing, collector tubing with elbow connector, collection canister with lid, and external power cord).There were no cracks present.There was no residue present.The stop valve was working properly.The pw collection system exhibited signs of function with returned accessories.Once the device was opened up, there was a small amount of residue on the base and the rim.Further inside, there was heavy residue and a mild amount of corrosion on the returned pcba.There was also a mild amount of pink and orange residue in the inner tubing next to the motor.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: ¿purewick¿urine collection system 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.Contact customer support at 1-888-201-1586 if any damage is observed.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 and contact customer support at 1-888-201-1586.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.To reduce the risk of electrical shock or injury, do not disassemble this unit.No modification of this equipment is allowed.Initial setup 1.Inspect the package for damage.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.2.Carefully remove all contents from the package, including the packing material and inspect prior to use.If any damage is noticed, contact customer support at 1-888-201-1586 immediately.3.Place the purewick¿ urine collection system (a) next to the bed or chair where it will be used.It must be close enough for the collector tubing with elbow connector (g) to easily reach the user and should be placed on a stable, even surface.For optimal results, position the purewick¿ urine collection system either on the floor or as close to the floor as your facility¿s protocol will allow.Note: the purewick¿ urine collection system should be stationary while in use.Device is not designed to be used while in transport.Caution: avoid creating a tripping hazard with the collector tubing or power cord.4.Plug the purewick¿ urine collection system power cord into device outlet (b) and into an a/c power outlet.Note: the device should be positioned for easy access to the a/c inlet and power cord.Note: make sure the power switch is turned off before connecting the power cord.¿ battery power operation (pw200 only) the built-in battery recharges any time the device is plugged into an outlet.To fully charge the battery, the system must be plugged in for 12 hours.The battery will supply 8 hours of backup power before requiring recharging.The purewick¿ urine collection system remains fully functional while the device is recharging.5.Place the collection canister (c) in the purewick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Optional (prior to sealing canister lid): while operating the purewick¿ urine collection system, ammonia odor for up to 1800 ml of urine can be eliminated by adding 2 teaspoons (10 grams) of vitamin c (ascorbic acid) powder into the collection canister before use.At least 99.93% of pure vitamin c (ascorbic acid) is recommended.If using the privacy cover (j), slip privacy cover onto canister (similar to a coffee cup sleeve) prior to placing canister into the base.Attach the pump tubing (d) to the purewick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.6.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Connect the other end of the collector tubing securely to a purewick¿ external catheter (i).Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system.7.Turn on the purewick¿ urine collection system by pressing the on/off switch.The purewick¿ urine collection system is working when the switch lights up green and the device makes a soft humming sound.The system is now ready for use.Operating instructions 1.After the purewick¿ urine collection system has been set up, place the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use.2.When the canister is ready to be emptied, remove the purewick¿ external catheter according to the purewick¿ external catheter¿s instructions for use and throw away.Note: keep the purewick¿ urine collection system on to make sure all urine has been drawn out of the collector tubing and into the collection canister before removing the purewick¿ external catheter.Note: although the canister can hold up to 2000cc (ml), to prevent overflow empty urine from the collection canister regularly or before volume reaches 1800cc (ml).3.Turn off the purewick¿ urine collection system by pressing the on/off switch.Disconnect the a/c power cord from the power outlet and from the device.Disconnect collector tubing and pump tubing from the canister.4.Lift collection canister from purewick¿ urine collection system.Do not lift canister by the lid.Take canister into an area appropriate for disposal e.G.A bathroom, carefully remove the lid, and dispose of urine in a proper receptacle e.G.A toilet or according to facility protocol.If using a privacy cover and it gets wet, remove and discard.5.Clean collector tubing, pump tubing, canister, purewick¿ urine collection system, and power cord according to cleaning instructions in the cleaning and maintenance section.6.Reassemble the purewick¿ urine collection system according to the initial setup instructions when the system is ready to be reused.When the purewick¿ urine collection system is not in use, unplug the power cord from its outlet.Make sure the unit is cleaned and disinfected prior to storage.Do not store when parts are wet or damp.Cleaning and maintenance inspect the purewick¿ urine collection system and accessories for damage or wear prior to use and replace as necessary.Do not attempt to open or dismantle the purewick¿ urine collection system.This may affect performance, create a potential safety hazard, cause personal injury, and will void the warranty.Always turn off the device and disconnect from power source prior to cleaning.The privacy cover components are single use only and should not be cleaned or disinfected.Point of use cleaning: after the completion of each use, the collection canister, canister lid, collector tubing, and pump tubing should be rinsed with cool tap water to remove any residual debris or dirt.The purewick¿ urine collection system base should be wiped with a clean low lint cloth dampened with cool tap water.Cleaning: prepare a soapy solution by mixing 1 teaspoon (approximately 5 ml) of dish soap with 1 gallon (approximately 4 l) of cool tap water.Fully submerge canister and lid in the solution.Allow it to sit for a minimum of ten (10) minutes.While submerged, use a soft brush (e.G.Toothbrush) to brush all accessible areas of the canister and lid for a minimum of one (1) minute to remove any visible signs of debris or dirt.¿ rinse: rinse the canister and the lid thoroughly with cool tap water until there is no visible sign of the cleaning solution.¿ visual inspection: inspect the canister and the lid to ensure that all debris and dirt have been removed.If there is any sign of debris or dirt, repeat steps above until there is no sign of debris or dirt remaining on the canister and lid.¿ disinfection: fully submerge the canister and lid in 70% isopropyl alcohol (ipa).Allow it to sit for a minimum of ten (10) minutes.¿ rinse: rinse the canister and the lid thoroughly with cool tap water.¿ drying: dry the canister and lid with a clean low lint towel or cloth.Collector tubing (with elbow connector) and pump tubing ¿ initial rinse: disconnect the collector tubing from the elbow connector and disconnect the elbow connector from the lid.Rinse the disconnected tubing thoroughly by running cool tap water through the inside of the tubing.While rinsing, remove any excess dirt by wiping the outside of the tubing and elbow connector with low lint disposable wipes.While rinsing, flush the tubing with cool tap water to remove any excess dirt.¿ cleaning: prepare a soapy solution by mixing 1 teaspoon (approximately 5 ml) of dish soap with 1 gallon (approximately 4 l) of cool tap water.Completely submerge the tubing and elbow connector in the solution and allow it to soak for a minimum of ten (10) minutes.At the beginning of the soak time, flush the inside of the tubing with the prepared solution.While submerged, use a soft brush (e.G.Toothbrush) to brush all accessible areas of the tubing and elbow connector for a minimum of one (1) minute to remove any visible signs of debris or dirt.¿ rinse: rinse the tubing and elbow connector thoroughly with cool tap water until there is no visible sign of the soap cleaning solution.While rinsing, flush the inside of the tubing with the tap water.¿ visual inspection: inspect the tubing to ensure that all debris and dirt have been removed.If there is any sign of debris or dirt, repeat the steps above until there is no sign of debris or dirt remaining on or inside the tubing.¿ disinfection: fully submerge the tubing and elbow connector in 70% isopropyl alcohol (ipa).Allow it to soak for a minimum of ten (10) minutes.Flush the ipa through the tubing, prior to starting the ten (10) minute time.¿ rinse: rinse the tubing and elbow connector thoroughly with cool tap water, ensuring that the inside of the tubing is flushed with water.¿ drying: dry the tubing and elbow connector outer surface with a clean low lint towel or cloth and allow the inside of the tubing to air dry for a minimum of thirty (30) minutes at room temperature.¿ initial wipe: wipe the purewicktm urine collection system base and power cord thoroughly with a clean low lint cloth dampened with cool tap water.Remove any excess dirt by wiping the device with disposable low lint wipes.¿ cleaning: prepare a soapy solution by mixing 1 teaspoon (approximately 5 ml) of dish soap with 1 gallon (approximately 4 l) of cool tap water.Completely wet a clean low lint cloth with the solution and wipe down the purewicktm urine collection system base and power cord.Allow the cleaning solution to remain on the device and power cord for a minimum of ten (10) minutes, ensuring that the device and power cord remains wet for the ten (10) minutes.Using a soft brush (e.G.Toothbrush), brush all accessible areas of the purewicktm urine collection system base and power cord for a minimum of one (1) minute to remove any visible signs of debris or dirt.¿ rinse: using a new clean low lint cloth, wipe the purewicktm urine collection system base and power cord thoroughly with cool tap water to remove the soap cleaning solution.Perform this step until there is no visible sign of the soap cleaning solution.¿ visual inspection: inspect the purewicktm urine collection system base and power cord to ensure that all debris and dirt have been removed.If there is any sign of debris or dirt, repeat the steps above until there is no sign of debris or dirt remaining on the purewicktm urine collection system base and power cord.¿ disinfection: use 70% isopropyl alcohol (ipa) to completely wet a clean low lint cloth and wipe down the purewicktm urine collection system base and power cord.Allow the disinfecting solution to remain on the device and power cord for a minimum of ten (10) minutes, ensuring the unit is visibly wet with ipa for ten (10) minutes.¿ rinse: using a new clean low lint cloth, wipe the purewicktm urine collection system base and power cord thoroughly with cool tap water to remove the disinfecting solution.¿ drying: dry the purewicktm urine collection system base and power cord with a clean low lint towel or cloth.Canister and canister lid (single user) ¿ initial rinse: rinse the canister and lid thoroughly with cool tap water.While rinsing, remove any excess dirt by wiping the canister and lid with disposable low lint wipes.¿ cleaning: prepare enzymatic cleaner solution (e.G.Enzol enzymatic cleaner or equivalent) following the manufacturer¿s recommendation of 1 oz.(approximately 29 ml) per gallon (approximately 4 l) of warm tap water (ratio and water temperature per manufacturer's recommendation if applicable).Completely submerge the canister and lid in the solution and allow it to soak for a minimum of ten (10) minutes.While the canister and lid are submerged, use a soft bristle brush (e.G.Toothbrush) to brush all accessible areas of the canister and lid for a minimum of one (1) minute to remove any visible signs of debris or dirt.¿ rinse: rinse the canister and the lid thoroughly with cool tap water until there is no visible sign of the enzymatic cleaning solution.¿ visual inspection: inspect the canister and the lid to ensure that all debris and dirt have been removed.If there is any sign of debris or dirt, repeat the steps above until there is no sign of debris or dirt remaining on the canister and lid.¿ drying: dry the canister and lid with a clean low lint towel or cloth.¿ disinfection: fully submerge the canister and lid in 70% isopropyl alcohol (ipa).Allow it to sit for a minimum of ten (10) minutes.¿ rinse: rinse the canister and the lid thoroughly with cool tap water.¿ drying: dry the canister and lid with a clean low lint towel or cloth.Replacing canister and tubing replace the canister and tubing for each patient per facility protocol or at least every 60 days, whichever is sooner.If you notice any of the following, replace immediately: ¿ canister or tubing has residual urine build-up ¿ canister or tubing appear cloudy ¿ canister or tubing appear discolored ¿ canister becomes cracked ¿ tubing becomes torn ¿ purewick¿ external catheter no longer securely connects to collector tubing failure to clean and/or replace accessories may affect the performance of the system.The useful life of the collection canister and tubing is 60 days.There are no serviceable parts in the purewick¿ urine collection system.Adjustments or modifications made by anyone other than an authorized representative of bd will void the warranty.If the purewick¿ urine collection system is not functioning properly after performing the troubleshooting steps, the device may have reached the end of its useful life.With normal use, this device shall remain safe for the useful life.Do not use the device if it is damaged or defective, including, but not limited to the following: ¿ cracks ¿ separated housing ¿ not suctioning properly or no suction ¿ damaged power cord disposal the purewick¿ urine collection system and accessories may be a potential biohazard.Clean and disinfect the purewick¿ urine collection system and accessories before disposal.Handle in accordance with accepted medical practice and applicable local and federal regulations.The purewick¿ urine collection system (pw100 and pw200) contains electrical and/or electronic equipment, and the when the purewick¿ urine collection system has been stored in a very warm environment (up to 158°f or 70°c), please allow the device to sit for approximately 90 minutes at room temperature (approximately 68°f or 20°c) before use.Physical specifications dimensions with canister: 9¿ x 6.5¿ x 11¿ (22.86cm x 16.51cm x 27.94cm) dimensions without canister: 8.75¿ x 6¿ x 7.5¿ (22.22cm x 15.24cm x 19.05cm) cord length: 12¿ (3.65m)¿ correction: d,f,h 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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