MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 8832539001

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 12/28/2021

Event Type  Injury  

Event Description

According to the reporter, a pediatric patient of (b)(6) with continuous veno-venous hemodialysis (cvvhd), hoses from hf20 set were connected directly to cdk of 8fr, 9cm.They had not made any interconnections.When they had started the continuous renal replacement therapy (crrt), they observed problems with negative output pressure.The nurse had tried to resolve the problem by reducing the blood flow, which has worked for a short time and suddenly, air has been detected in cdk ladle and hf20 output hose.The treatment has been discontinued and the cdk aspirational and control was x-rayed.They have slightly changed the position of the cdk (more superficial) and they were not able to push in anymore and decided to pull cdk.There was an about 50-60 ml of blood loss.There was no reported patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a pediatric patient of 10 kilograms with continuous veno-venous hemodialysis (cvvhd), hoses from hf20 set were connected directly to cdk of 8fr, 9cm.They had not made any interconnections.When they had started the continuous renal replacement therapy (crrt), they observed problems with negative output pressure.The nurse had tried to resolve the problem by reducing the blood flow, which has worked for a short time and suddenly, air has been detected in the red lumen of the cdc and also in hf20 red output hose.The treatment has been discontinued and the cdk aspirational was controlled, and x-ray of the cdc position was made.They have slightly changed the position of the cdk (more superficial) and they were not able to push in anymore and decided to pull the cdk.The crrt was ended and the patient was not dialysis anymore.Nothing unusual was observed on the device prior to use, flushing was performed with normal result, there was no other product utilized with the device, there was no other defects/damages fo und on the product, there was no leak and there was no luer adapter issue.It was also stated that klorhexidin (alcohol) was used as the cleaning agent on the device before connecting the tubing and to treat the insertion site prior to product placement.There wasno medical intervention done to the patient, the blood returned was flush with syringe prior to use, heparin was used as the anti-coagulant, the reverse flow was successfully performed and the hard line was not flushed prior to use.There was an about 50-60 ml (milliliter) of blood loss and blood transfusion was not required.The patient was recovered.

Manufacturer Narrative

Additional information: b5, d6a, d6b, e1 ( first and last name, phone number), e2, e3, e4 (email), g2, g3 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, a pediatric patient of 10 kilograms with continuous veno-venous hemodialysis (cvvhd), hoses from hf20 (filter) set were connected directly to catheter of 8fr, 9cm.They did not make any interconnections.When the continuous renal replacement therapy (crrt) was started, negative output pressure was observed.The nurse tried to resolve the problem by reducing the blood flow, which worked for a short time but suddenly, air was detected in the red lumen of the catheter and also in the hf20 red output hose.The treatment was discontinued and cdk aspirational was controlled, and x-ray of the catheter position was made.They have slightly changed the position of the catheter (more superficial) and was not able to push in anymore, and they decided to pull the cdk.The crrt was ended and the patient's dialysis was not continued anymore.Nothing unusual was observed on the device prior to use, flushing was performed with normal result, there was no other product utilized with the device, there were no other defects/damages found on the product, there was no leak, and there was no luer adapter issue.It was also stated that klorhexidin (alcohol) was used as the cleaning agent on the device before connecting the tubing and to treat the insertion site prior to product placement.There was no medical intervention done to the patient, the blood returned was flush with syringe prior to use, heparin was used as the anti-coagulant, the reverse flow was successfully performed, and the hard line was not flushed prior to use.There was an about 50-60 ml (milliliter) of blood loss and blood transfusion was not required.The patient had recovered.

Manufacturer Narrative

Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was an insufficient flow issue.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, a pediatric patient of 10 kilograms with continuous veno-venous hemodialysis (cvvhd), hoses from hf20 (filter) set were connected directly to catheter of 8fr, 9cm.They did not made any interconnections.When the continuous renal replacement therapy (crrt) was started, negative output pressure was observed.The nurse tried to resolved the problem by reducing the blood flow, which has worked for a short time but suddenly, air was been detected in the red lumen of the catheter and also in the hf20 red output hose.The treatment was discontinued andc catheter aspirational was controlled, and x-ray of the catheter position was made.They have slightly changed the position of the catheter (more superficial), and was not able to push in anymore, and they decided to pull the catheter.The crrt was ended and the patient's dialysis was not continued anymore.Nothing unusual was observed on the device prior to use, flushing was performed with normal result, there was no other product utilized with the device, there was no other defects/damages found on the product, there was no leak and there was no luer adapter issue.It was also stated that klorhexidin (alcohol) was used as the cleaning agent on the device before connecting the tubing and to treat the insertion site prior to product placement.There was no medical intervention done to the patient, the blood returned was flush with syringe prior to use, heparin was used as the anti-coagulant, the reverse flow was successfully performed and the hard line was not flushed prior to use.There was an about 50-60 ml (milliliter) of blood loss and blood transfusion was not required.The patient had recovered.

Manufacturer Narrative

Additional information: b5, g3 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.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13376336
• MDR Text Key: 284613632
• Report Number: 3009211636-2022-00026
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005303
• UDI-Public: 10884521005303
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Model Number: 8832539001
• Device Catalogue Number: 8832539001
• Device Lot Number: 1814300192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2018
• 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): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 10 KG