MAUDE Adverse Event Report: ORIGEN BIOMEDICAL INC. ECMO DOUBLE LUMEN VV CANNULA 28 F; CANNULA, CATHETER

Catalog Number VV28F

Device Problems Disconnection (1171); Physical Property Issue (3008)

Patient Problem Blood Loss (2597)

Event Date 11/23/2016

Event Type  malfunction  

Event Description

Patient was on vv ecmo, venous side of double lumen cannula came disconnected from company manufactured y site causing blood loss and temporary disconnection from ecmo circuit.Patient with additional venous cannula allowing maintaining of some ecmo support while preparing to change out double lumen cannula.Patient again required removal of ecmo support while replacing damaged equipment.Breakage of equipment caused patient to be removed from ecmo x3, blood loss that required additional 2 units of prbc's during and after event, required patient to be reintubated, exposed patient to possible contamination by having disconnection/breakage of ecmo cannula and exposing open central access to non-sterile environment.The patient appears to have returned to baseline.As far as what happened, our speculation is that the manufactured glue failed at the y connection.The patient had the cannula in place for several weeks.The patient had a second cannula in her groin area that did not pose any concerns or issues.

Event Description

Patient was on vv ecmo, venous side of double lumen cannula came disconnected from company manufactured y site causing blood loss and temporary disconnection from ecmo circuit.Patient with additional venous cannula allowing maintaining of some ecmo support while preparing to change out double lumen cannula.Patient again required removal of ecmo support while replacing damaged equipment.Breakage of equipment caused patient to be removed from ecmo x3, blood loss that required additional 2 units of prbc's during and after event, required patient to be reintubated, exposed patient to possible contamination by having disconnection/breakage of ecmo cannula and exposing open central access to non-sterile environment.The patient appears to have returned to baseline.As far as what happened, our speculation is that the manufactured glue failed at the y connection.The patient had the cannula in place for several weeks.The patient had a second cannula in her groin area that did not pose any concerns or issues.

Event Description

Patient was on vv ecmo, venous side of double lumen cannula came disconnected from company manufactured y site causing blood loss and temporary disconnection from ecmo circuit.Patient with additional venous cannula allowing maintaining of some ecmo support while preparing to change out double lumen cannula.Patient again required removal of ecmo support while replacing damaged equipment.Breakage of equipment caused patient to be removed from ecmo x3, blood loss that required additional 2 units of prbc's during and after event, required patient to be reintubated, exposed patient to possible contamination by having disconnection/breakage of ecmo cannula and exposing open central access to non-sterile environment.The patient appears to have returned to baseline.As far as what happened, our speculation is that the manufactured glue failed at the y connection.The patient had the cannula in place for several weeks.The patient had a second cannula in her groin area that did not pose any concerns or issues.The facility has maintained this product and have made it available for inspection to the manufacturer.We have shared details regarding the event and what happened to the patient.We shared detailed pictures that they (manufacturer) requested of the external and internal aspects of the cannula pieces.They in turn updated us on their failure testing and that they were able to replicate the event by placing a clamp on the clear section of tubing very close to the hub that seemed to create a stress fracture in the adhesive that predisposed weakness leading to failure.(we are not aware that a clamp was related to the event we experienced.) they shared that this cannula was among a lot from several years ago and that no one else has reported this event.They felt it was an isolated event and although the failure potential is present, unlikely to recur.They have created a technical bulletin that we were told would go to all customers who have ordered this product in the past few years and also with future product purchases.They verbalized plans to redesign the adhesive bonding process to address this issue.The company has been responsive in an effect to evaluate this issue.

• Brand Name: ECMO DOUBLE LUMEN VV CANNULA 28 F
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL INC.; 7000 burleson rd.; bldg. d; austin TX 78744
• MDR Report Key: 6215664
• MDR Text Key: 63645842
• Report Number: 6215664
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2016,12/07/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: VV28F
• Device Lot Number: N18487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2016
• Device Age: 14 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2017; 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.; UNKNOWN.
• Patient Age: 7 YR
• Patient Weight: 50