|
PERFUSION SYSTEMS KIT 96553 BIO-MEDICUS PEDIATRIC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
| Model Number 96553 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Hemorrhage/Bleeding (1888); Venipuncture (2129)
|
| Event Date 11/01/2016 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Citation: doi:10.3969 /j.Issn.1674-4748.2016.32.Lead author: hu jing.Article title: nursing of extracorporeal membrane oxygenation technology in pediatrics.Journal title: chinese general practice nursing.Publish date: november 2016.Volume: 14.Issue: 32.Date of publish used for event date.Cannula model cb12008 was entered as a placeholder as specific model and lot numbers were not provided no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported.Majority gender of study population used for patient gender.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Medtronic received information via literature regarding a study exploring the nursing measures of extracorporeal membrane oxygenation (ecmo) in pediatric critically ill children.All data were collected from a single center between december 2011 and december 2015.The study population included 28 patients (18male and 10 female), aged 1 - 13 years old (mean age: ( 3.39 years old ± 4.22 years old) of which were treated with the following medtronic devices [minimax plus oxygenator; pediatric bio-pump centrifugal pump; bio-console 560 pump speed controller; biotrend® oxygenation saturation and hematocrit monitor; custom tubing pack; dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits (serial numbers not provided).Among all patients, 10 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: 32 cases of non-mechanical complications: 12 cases of neurological complications, including 4 cases of cerebral infarction and convulsions, 2 cases of intracranial hemorrhage and 1 cases of internal jugular vein thrombosis and cerebral atrophy after ligation.Hemorrhage complications occurred in 12 cases, including 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site, 2 cases of intracranial hemorrhage and 1 case of spontaneous hematoma.1 patient had a femoral vein puncture via catheter, post-peritoneal hemorrhage (could not stop bleeding) and stopped ecmo treatment, acute renal injury (aki) occurred in 5 cases, microcirculation thrombosis occurred 3 times.Based on the available information, the following adverse events may be attributable to the dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits: 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site and 1 femoral vein puncture via catheter.Based on the available information, the deaths were not attributed to medtronic product.Among all patients, no device malfunctions were noted.No additional adverse patient effects or product performance issues were reported.
|
| |
|
Event Description
|
|
Medtronic received information via literature regarding a study exploring the nursing measures of extracorporeal membrane oxygenation (ecmo) in pediatric critically ill children.All data were collected from a single center between december 2011 and december 2015.The study population included 28 patients (18male and 10 female), aged 1 - 13 years old (mean age: ( 3.39 years old ± 4.22 years old) of which were treated with the following medtronic devices [minimax plus oxygenator; pediatric bio-pump centrifugal pump; bio-console 560 pump speed controller; biotrend® oxygenation saturation and hematocrit monitor; custom tubing pack; dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits (serial numbers not provided).Among all patients, 10 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: 32 cases of non-mechanical complications: 12 cases of neurological complications, including 4 cases of cerebral infarction and convulsions, 2 cases of intracranial hemorrhage and 1 cases of internal jugular vein thrombosis and cerebral atrophy after ligation.Hemorrhage complications occurred in 12 cases, including 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site, 2 cases of intracranial hemorrhage and 1 case of spontaneous hematoma.1 patient had a femoral vein puncture via catheter, post-peritoneal hemorrhage (could not stop bleeding) and stopped ecmo treatment, acute renal injury (aki) occurred in 5 cases, microcirculation thrombosis occurred 3 times.Based on the available information, the following adverse events may be attributable to the dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits: 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site and 1 femoral vein puncture via catheter.Based on the available information, the deaths were not attributed to medtronic product.Among all patients, no device malfunctions were noted.No additional adverse patient effects or product performance issues were reported.
|
| |
|
Manufacturer Narrative
|
|
Investigation conclusion: medtronic cannot confirm or deny the complaint of an error or an issue with the device resulting in the occurrences identified in the literature review as no picture was provided and no device has been returned.A root cause of these occurrence cannot be determined without a returned device.In addition, the device is not supposed to be used for ecmo per the ifu.The device history record could not be reviewed as a lot number was not provided.If additional information is received, this complaint will be reopened and the investigation will be updated as required.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.
|
| |
|
Manufacturer Narrative
|
|
Correction: h - coding added following investigation completion.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.
|
| |
|
Event Description
|
|
Medtronic received information via literature regarding a study exploring the nursing measures of extracorporeal membrane oxygenation (ecmo) in pediatric critically ill children.All data were collected from a single center between december 2011 and december 2015.The study population included 28 patients (18male and 10 female), aged 1 - 13 years old (mean age: ( 3.39 years old ± 4.22 years old) of which were treated with the following medtronic devices [minimax plus oxygenator; pediatric bio-pump centrifugal pump; bio-console 560 pump speed controller; biotrend® oxygenation saturation and hematocrit monitor; custom tubing pack; dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits (serial numbers not provided).Among all patients, 10 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: 32 cases of non-mechanical complications: 12 cases of neurological complications, including 4 cases of cerebral infarction and convulsions, 2 cases of intracranial hemorrhage and 1 cases of internal jugular vein thrombosis and cerebral atrophy after ligation.Hemorrhage complications occurred in 12 cases, including 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site, 2 cases of intracranial hemorrhage and 1 case of spontaneous hematoma.1 patient had a femoral vein puncture via catheter, post-peritoneal hemorrhage (could not stop bleeding) and stopped ecmo treatment, acute renal injury (aki) occurred in 5 cases, microcirculation thrombosis occurred 3 times.Based on the available information, the following adverse events may be attributable to the dlp left heart vent catheter and bio-medicus nextgen insertion arterial/venous kits: 5 hemorrhages at the puncture site, 4 hemorrhages in the ecmo catheterization site and 1 femoral vein puncture via catheter.Based on the available information, the deaths were not attributed to medtronic product.Among all patients, no device malfunctions were noted.No additional adverse patient effects or product performance issues were reported.
|
| |
|
Search Alerts/Recalls
|
|
|
