MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.

Event Description

According to the reporter, a 75-year-old patient, who had a haemodialysis central venous catheter (cvc) attended a specialist unit f or haemodialysis treatment.While there, she reported feeling unwell and was transferred to hospital, with a suspected infection of her toe.The patient was admitted to an older person¿s ward for ongoing treatment and to further explore the source of the infection.Blood test results had shown the presence of a specific type of bacteria and the patient received antibiotic medication.To exclude the possibility of the bacteria being in the patient¿s haemodialysis cvc, advice was given to take blood cultures from the line.A medical student, supervised by a junior doctor, volunteered to take the blood cultures.They understood the patient had a central line (a tube that is placed in vein in the neck to give fluids, blood, or medications).When they saw the patient, they realized the haemodialysis cvc looked different to other central lines they had seen previously.A cap was removed from the haemodialysis cvc and while the medical student was cleaning the end of the line, the junior doctor unclamped it.After approximately four minutes, the patient collapsed and suffered a cardiac arrest.She was successfully resuscitated and was transferred to the hospital intensive care unit, but died two days later.The department of health and social care (dhsc) reported their concerns following a coroner¿s inquest during which a report to prevent future deaths (pfd) was issued from hm coroner.The inquest concluded that a possible contributory cause of the patient¿s death was a cardiac arrest, which was ¿probably secondary to air embolus¿.It was thought this may have occurred when the haemodialysis cvc was uncapped and unclamped.

Event Description

According to the reporter, a 75-year-old patient, who had a haemodialysis central venous catheter (cvc) attended a specialist unit f or haemodialysis treatment.While there, she reported feeling unwell and was transferred to hospital, with a suspected infection of her toe.The patient was admitted to an older person¿s ward for ongoing treatment and to further explore the source of the infection.Blood test results had shown the presence of a specific type of bacteria and the patient received antibiotic medication.To exclude the possibility of the bacteria being in the patient¿s haemodialysis cvc, advice was given to take blood cultures from the line.A medical student, supervised by a junior doctor, volunteered to take the blood cultures.They understood the patient had a central line (a tube that is placed in vein in the neck to give fluids, blood, or medications).When they saw the patient, they realised the haemodialysis cvc looked different to other central lines they had seen previously.A cap was removed from the haemodialysis cvc and while the medical student was cleaning the end of the line, the junior doctor unclamped it.After approximately four minutes, the patient collapsed and suffered a cardiac arrest.She was successfully resuscitated and was transferred to the hospital intensive care unit, but died two days later.The department of health and social care (dhsc) reported their concerns following a coroner¿s inquest during which a report to prevent future deaths (pfd) was issued from hm coroner.The inquest concluded that a possible contributory cause of the patient¿s death was a cardiac arrest, which was ¿probably secondary to air embolus¿.It was thought this may have occurred when the haemodialysis cvc was uncapped and unclamped.It was stated that based from the investigation, the issue did not involve a medtronic devices, however, they did use a data about other events occurring to inform us of the prevalence of events, but this data did not expose which device or manufacturer of the device was in use.

Manufacturer Narrative

Additional information: b5, b6, g3, h6 (fdd) 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.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16505216
• MDR Text Key: 310905934
• Report Number: 1219930-2023-00900
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• 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: 75 YR
• Patient Sex: Female