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The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure could be due to "incorrect/ missing translation; vendor/printer error ".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.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 instruction: 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.Inspect the purewick¿ urine collection system and accessories for damage or wear prior to use and replace as necessary.Discontinue use if an allergic reaction occurs.Not recommended for users who are experiencing skin irritation or skin breakdown in device contact areas.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.Trouble shooting information: symptom : the device does not turn on when external power is used.Check the following : check that the power cord is plugged into the purewick¿ urine collection system and to an electrical outlet.Symptom : the power switch does not glow when turned on.Check the following : ensure the electrical outlet is functioning by plugging in another electrical device.Symptom : the device is on but is not suctioning properly.Check the following : 1.Ensure tubing connections are connected properly.2.Check collector tubing for blockage or flow restriction such as pinched or kinked tubing.3.Ensure overflow stop valve in collection canister lid is open.The valve floats to the top when the collection canister is full.The stop valve may close if the lid or canister is tipped sideways or upside down.Disconnect tubing and gently shake the lid to reset the valve down to the open position.4.Ensure collection canister is sealed with the lid tightly closed.5.Verify suction by disconnecting purewick¿ external catheter from the collector tubing and placing the end of the collector tubing into a cup of water.If water easily flows into the collection.Canister replace the purewick¿ external catheter.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." the device was not returned.
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It was reported that the patient was getting a lot of infections.The purewick accessory canister kit was cracked, it should have better directions and purewick urine collection system motor was not running, and patient threw machine away.It was noted that patient had been using products for more than 90 days.It was unknown what medical intervention was provided for infections and if the purewick female external catheter contributed to infections.
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Per additional information received from ucc, it has been determined that this mdr event is not reportable.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 device was not returned.
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It was reported that the patient was getting a lot of infections.The purewick accessory canister kit was cracked, it should have better directions and purewick urine collection system motor was not running, and patient threw machine away.It was noted that patient had been using products for more than 90 days.
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