It was reported that the patient confirmed 10 cassettes that are affected by recall and 1 cassette (of another lot) which had occlusion and had alarm going off.The patient reported the blue cap that prevents medication from going back has not worked properly and has led to leakage.There was 1 cassette that had cracked and had to be sent back to the manufacturer about 2 months ago.The patient sometimes gets feeling of "bolus" where they feel have gotten too much of medication, leading to feeling sick and dizzy.This normally happened when there was only about 50ml of medication left on the cassette.The patient's medical doctor ended up increasing the dose due to having trouble with walking distances, but unsure if it was because of patient condition or due to pump malfunction.No patient injury reported.
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
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