MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888135191

Device Problems Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  Injury  

Event Description

According to the reporter, the patient came to the out-patient clinic of the hospital for dialysis treatment due to uremia.The patient used the machine at 17:34.After 30 minutes of using the machine (on-boarded), blood flow was poor and machine alarmed frequently.After treatment by the nursing staff, blood flow rate was 180 ml to maintain dialysis.At 3 hours, the venous pressure was greater than 500 mmhg.The normal saline was used to flush the tube.Severe coagulation of the dialyzer and pipeline/tubing (grade 3) was seen, considering that the patient had poor catheter function, about 250 ml of blood was discarded in the extracorporeal circulation.They replace the dialyzer and the line bleeder.It was stated that the procedure was correct and this event was considered to be caused by the product with poor catheter function.The patient¿s vital signs were closely observed and blood analysis was performed regularly.The patient¿s vital signs fluctuated which affected the doctor¿s treatment effect causing serious injury to the patient¿s body.

Manufacturer Narrative

Concomitant medical products: unk - rcs - unknown renal care product, lot# unknown.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

According to the reporter, the catheter had been implanted nearly 1 month, the patient came to the out-patient clinic of the hospital for dialysis treatment due to uremia.The patient used the machine at 17:34.After 30 minutes of using the machine (on-boarded), blood flow was poor, there was insufficient flow and machine alarmed frequently.It was also sated that there was a leak found at the extension tube.After treatment by the nursing staff, blood flow rate was 180 ml to maintain dialysis.At 3 hours, the venous pressure was greater than 500 mmhg.The normal saline was used to flush the tube.Severe coagulation of the dialyzer and pipeline/tubing (grade 3) was seen, considering that the patient had poor catheter function, about 250 ml of blood was discarded in the extracorporeal circulation.The catheter was not repaired.Tego was not utilized and there was no luer adapter issue.Disinfectant was used as a cleaning agent on the device.The was no cleaning agent used to treat the insertion site prior to product placement.There was no thing unusual observed on the device prior to use, no other defects/damages were found on the product and aside from dialyzer and bloodlines there were no other products utilized with the device.Flushing was not done prior to use.The line was not hard to flush with the syringe, reverse flow was successful and there was blood return prior to syringe flush.There was no infusion line.Heparin was the anticoagulant used.They replace the dialyzer and the line bleeder and adjusted the position to resolve the issue.Treatment was completed.Patient's blood pressure decreased (lowered) after the issue was resolved.It was stated that the procedure was correct and this event was considered to be caused by the product with poor catheter function.The patient¿s vital signs were closely observed and blood analysis was performed regularly.The patient¿s vital signs fluctuated which affected the doctor¿s treatment effect causing serious injury to the patient¿s body as a result of the event.The serious injury that the patient had was loss of about 250ml of extracorporeal circulation blood.Blood transfusion was not required.There was no intervention/ medical treatment required as a result of the event.The patient had infection as a result of poor catheter function.

Manufacturer Narrative

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

Additional information: b5, d4 (model and catalog number), g3, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.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

According to the reporter, the catheter had been implanted nearly 1 month, the patient came to the out-patient clinic of the hospital for dialysis treatment due to uremia.The patient used the machine at 17:34.After 30 minutes of using the machine (on-boarded), blood flow was poor, there was insufficient flow and machine alarmed frequently.It was also stated that there was blood leak found at the venous extension tube close to the luer adapter.There were no other defects/damages found at the leakage part.After treatment by the nursing staff, blood flow rate was 180 ml to maintain dialysis.At 3 hours, the venous pressure was greater than 500 mmhg.The normal saline was used to flush the tube.Severe coagulation of the dialyzer and pipeline/tubing (grade 3) was seen, considering that the patient had poor catheter function, about 250 ml of blood was discarded in the extracorporeal circulation.The catheter was not repaired.Tego was not utilized and there was no luer adapter issue.Disinfectant was used as a cleaning agent on the device.The was no cleaning agent used to treat the insertion site prior to product placement.There was nothing unusual observed on the device prior to use, no other defects/damages were found on the product and aside from dialyzer and bloodlines there were no other products utilized with the device.Flushing was not done prior to use.The line was not hard to flush with the syringe, reverse flow was successful and there was blood return prior to syringe flush.There was no infusion line.Heparin was the anticoagulant used.They replace the dialyzer and the line bleeder and catheter was repositioned to resolve the issue.The catheter did no move out of placed and there were no tools used for repositioning.Treatment was completed.Patient's blood pressure decreased (lowered) after the issue was resolved.It was stated that the procedure was correct and this event was considered to be caused by the product with poor catheter function.The patient¿s vital signs were closely observed and blood analysis was performed regularly.The patient¿s vital signs fluctuated which affected the doctor¿s treatment effect.The patient had blood loss of about 250ml of extracorporeal circulation blood.Blood transfusion was not required.There was no intervention/medical treatment required as a result of the event.The patient did not have a confirmed infection as a result of poor catheter function.And there was no prophylactic antibiotic given to the patient to prevent the infection.There was no patient injury.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15754171
• MDR Text Key: 303261485
• Report Number: 3009211636-2022-00390
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135191
• Device Catalogue Number: 8888135191
• Device Lot Number: 20220912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 12/07/2022
• Supplement Dates FDA Received: 12/06/2022; 12/22/2022
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other