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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC AFFINITY TUBING, PUMP, CARDIOPULMONARY BYPASS

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MEDTRONIC, INC AFFINITY TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number 221012002
Device Problem Fluid Leak (1250)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Event Date 03/19/2021
Event Type  Death  
Event Description
Extracorporeal membrane oxygenation (ecmo) cone was decoupled today at 11:06. Cone was at its hour 65. Patient's bp and o2 saturation immediately dropped and cpr started at 11:07. Epinephrine was pushed, cpr was initiated. Cone was changed by two perfusionists at 11:09 and code stopped at 11:10. Patient stable. This is a venovenous ecmo patient. Had first circuit changeout 7 days before the event date, changeout was 38sec. Patient proceeded to code, desaturation 2min with cpr, resulting in increased chest tube output. The new oxygenator was found to leak blood, but since it was minimal the risk/ benefit was discussed, and we would continue to monitor oxygenator performance in co2 post membrane results. 3 days before the event date, icu team decided to changeout ecmo circuit again, resulting in patient desaturation, bradycardia with epi support. Today, on the day of the event, 1100 the existing cone @65hrs decoupled (magnets splitting). The previous cones were all stable at time of changeout of 100hrs and 319hrs. We have saved this cone for further investigation. There was no reported clots or noise prior to decoupling. This patient was declared do-not-resuscitate order (dnr). Family was contacted for withdrawal. We don't have an estimated life predictor, but they on average last longer than the oxygenators. The previous cone life was at 319hrs and 100 hrs respectively. The protocol for backup and changeout was follow-up and took only 2 minutes for changeout which is impressive for emergency situation.
 
Event Description
Extracorporeal membrane oxygenation (ecmo) cone was decoupled today at 11:06. Cone was at its hour 65. Patient's bp and o2 saturation immediately dropped and cpr started at 11:07. Epinephrine was pushed, cpr was initiated. Cone was changed by two perfusionists at 11:09 and code stopped at 11:10. Patient stable. This is a venovenous ecmo patient. Had first circuit changeout 7 days before the event date, changeout was 38sec. Patient proceeded to code, desaturation 2min with cpr, resulting in increased chest tube output. The new oxygenator was found to leak blood, but since it was minimal the risk/ benefit was discussed, and we would continue to monitor oxygenator performance in co2 post membrane results. Three days before the event date, icu team decided to changeout ecmo circuit again, resulting in patient desaturation, bradycardia with epi support. Today, on the day of the event, 1100 the existing cone @65hrs decoupled (magnets splitting). The previous cones were all stable at time of changeout of 100hrs and 319hrs. We have saved this cone for further investigation. There was no reported clots or noise prior to decoupling. This patient was declared do-not-resuscitate order (dnr). Family was contacted for withdrawal. We don't have an estimated life predictor, but they on average last longer than the oxygenators. The previous cone life was at 319hrs and 100 hrs respectively. The protocol for backup and changeout was follow-up and took only 2 minutes for changeout which is impressive for emergency situation.
 
Event Description
Extracorporeal membrane oxygenation (ecmo) cone was decoupled today at 11:06. Cone was at its hour 65. Patient's bp and o2 saturation immediately dropped and cpr started at 11:07. Epinephrine was pushed, cpr was initiated. Cone was changed by two perfusionists at 11:09 and code stopped at 11:10. Patient stable. This is a venovenous ecmo patient. Had first circuit changeout 7 days before the event date, changeout was 38sec. Patient proceeded to code, desaturation 2min with cpr, resulting in increased chest tube output. The new oxygenator was found to leak blood, but since it was minimal the risk/ benefit was discussed, and we would continue to monitor oxygenator performance in co2 post membrane results. Three days before the event date, icu team decided to changeout ecmo circuit again, resulting in patient desaturation, bradycardia with epi support. Today, on the day of the event, 1100 the existing cone @65hrs decoupled (magnets splitting). The previous cones were all stable at time of changeout of 100hrs and 319hrs. We have saved this cone for further investigation. There was no reported clots or noise prior to decoupling. This patient was declared do-not-resuscitate order (dnr). Family was contacted for withdrawal. We don't have an estimated life predictor, but they on average last longer than the oxygenators. The previous cone life was at 319hrs and 100 hrs respectively. The protocol for backup and changeout was follow-up and took only 2 minutes for changeout which is impressive for emergency situation.
 
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Brand NameAFFINITY
Type of DeviceTUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC
MDR Report Key11634078
MDR Text Key244434698
Report Number11634078
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 03/25/2021,03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number221012002
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Event Location Hospital
Date Report to Manufacturer04/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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