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Model Number IBP4374 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Protective Measures Problem (3015)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2022 |
Event Type
malfunction
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Event Description
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According to the reporter, 3 hours at the start of hdf (hemodiafiltration) for the patient with end stage renal disease, the nurse noticed a blood leak at the top welding seam of the dialyzer.The place where the potting (top and bottom) of the dialyzer is welded on the dialyzer itself where the blood came in from the connected bloodline.There was no defects/damages found on the product.There was a blood leakage alarm activated.It was also stated that there were blood transfusions done.Priming was done and the result was normal.There was nothing unusual observed on the device prior to use.Only the bloodline was the product being utilized with the device with nothing unusual detected.There was nothing other defects/damages found on the product where the leak was observed.There were no components replaced.Dialysis was successfully finished after the switch of the membrane.There was no patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: g3, h6 new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, three hours after the start of hdf (hemodiafiltration) for the patient with end stage renal disease, the nurse noticed a blood leak at the top welding seam of the dialyzer - the place where the potting (top and bottom) was welded on the dialyzer where the blood came in from the connected bloodline.It was also visible inside the dialyzer housing and visible in the dialysate outlet tubing towards the machine.There was a blood leakage alarm activated.Priming was done and the result was normal.There was nothing unusual observed on the device prior to use.Only the bloodline was the product being utilized with the device with nothing unusual detected.There was nothing other defects/damages found on the product where the leak was observed.There were no components replaced.There was no switch of the membrane done as it was close to the end of treatment, treatment was stopped after.There was no patient injury.
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Search Alerts/Recalls
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