MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96820-112

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Blood Loss (2597)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of a bio-medicus paediatric femoral arterial cannula, the cannula was initially secured in position using the suture collar.However during the procedure, on day 5, the cannula came out, resulting in the extra corporeal membrane oxygenation (ecmo) machine having to be stopped.The patient was re-cannulated and ecmo resumed.Ecmo down time before re-cannulation and restart of ecmo was 25 minutes, during which the patient was resuscitated with cpr.The decannulation resulted in some blood loss (amount asked but unknown), which resulted in a blood transfusion.Patient condition was described as critical but stable, but this was reported as expected for a child with this medical condition on ecmo.It is not possible to determine at this stage if there is ongoing patient morbidity/harm associated with the event.Underlying condition requiring ecmo treatment was a dysrhythmia.This was veno-arterial (va) ecmo.Drainage from right internal jugular with return to right common carotid artery.Cut down procedure.Cannula secured with mersilk.The skin was sutured, tied around the moveable cuff and secure to the child¿s neck.Covered with tegaderm dressing.The attending physician believed the cuff may have been too loose but the medtronic sales rep had a face to face conversation with the initial reporter following.The sales rep and initial reporter examined both the retrieved cannula and a demonstration nextgen 96820 cannulae from the sales rep's kit bag.The sales rep and initial reporter could not see any obvious differences between the cuff and on manual manipulation there did not appear to be excessive movement.It had been noted in the patient medical record that the return catheter had appeared high on imaging.The sales rep asked to explain the comment.It was felt the patient¿s return cannula was not inserted as fully as would usually be expected.Following the sales reps discussion with the reporter it was felt by the reporter that the device was unlikely to be at fault but obviously wanted it examined by medtronic for the hospital¿s own incident reporting.

Event Description

Medtronic received information that during use of a bio-medicus pediatric femoral arterial cannula, the cannula was initially secured in position using the suture collar.However during the procedure, on day 5, the cannula came out, resulting in the extra corporeal membrane oxygenation (ecmo) machine having to be stopped.The patient was re-cannulated and ecmo resumed.Ecmo down time before re-cannulation and restart of ecmo was 25 minutes, during which the patient was resuscitated with cpr.The decannulation resulted in some blood loss (amount asked but unknown), which resulted in a blood transfusion.Patient condition was described as critical but stable, but this was reported as expected for a child with this medical condition on ecmo.It is not possible to determine at this stage if there is ongoing patient morbidity/ harm associated with the event.Underlying condition requiring ecmo treatment was a dysrhythmia.This was veno-arterial (va) ecmo.Drainage from right internal jugular with return to right common carotid artery.Cut down procedure.Cannula secured with mersilk.The skin was sutured, tied around the moveable cuff and secure to the child¿s neck.Covered with tegaderm dressing.The attending physician believed the cuff may have been too loose but the medtronic sales rep had a face to face conversation with the initial reporter following.The sales rep and initial reporter examined both the retrieved cannula and a demonstration nextgen 96820 cannulae from the sales rep's kit bag.The sales rep and initial reporter could not see any obvious differences between the cuff and on manual manipulation there did not appear to be excessive movement.It had been noted in the patient medical record that the return catheter had appeared high on imaging.The sales rep asked to explain the comment.It was felt the patient¿s return cannula was not inserted as fully as would usually be expected.Following the sales reps discussion with the reporter it was felt by the reporter that the device was unlikely to be at fault but obviously wanted it examined by medtronic for the hospital¿s own incident reporting.

Manufacturer Narrative

Medtronic investigation: medtronic cannot confirm the complaint of a loose suture collar as analysis of the returned device did not show any damage and was within specification.After evaluation it was determined that the root cause is unknown.The device history record was not reviewed as there is no evidence of manufacturing issues with the device.A review of previous similar complaints for this model number found no similar occurrences.Assessment against the medtronic risk management file dfmeca document indicates that the current risk zone does not exceed the risk zone predicted in the product dfmeca; therefore, no capa will be initiated at this time.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Medtronic will continue to monitor for future occurrences and trends.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: BIO-MEDICUS NG PEDIATRIC ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10419963
• MDR Text Key: 203353271
• Report Number: 2184009-2020-00043
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96820-112
• Device Catalogue Number: 96820-112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO
• Patient Weight: 6