MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number CB5P05R8

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Hypoxia (1918); Respiratory Failure (2484); Blood Loss (2597)

Event Date 06/25/2020

Event Type  Death  

Manufacturer Narrative

Visual analysis: visual inspection shows evidence of a crack in the body of the device.Device was cleaned using a 10% bleach solution.Performance analysis: pressure integrity testing was performed 20 psi for 2 minutes.During the test, there was a leak observed from the device.Conclusion; review of documentation of the reported work order found that this catalog was manufactured according to specification (dry connection and tie bands).There was not found any issues related to the reported failure mode during the investigation of the event.Component was assembly without any chemical that could damage the component that let the leaking.Product analysis shows evidence of cracks in the body of the device at the molding gate location.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a custom tubing pack, during regular circuit replacement, a crack was noted in the flow cell in the circuit after stopping alcohol use.It was replaced with a non-medtronic adult circuit, it was said that the product was still in use.The crack was on the tube connect part.Effects on the patient; blood loss due to circuit replacement for twice and blood leakage from the crack (when confirming the amount of blood, it is the level of oozing out, but cannot be expressed in units).It was reported that the patient died.Cause of death and date of death have not been confirmed.In addition, on june 29, a similar phenomenon occurred with a non-medtronic (terumo cdi) cell that was later assembled in the same circuit, and it was necessary to investigate the cause and take future measures.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information received reported that cracks were found in the front and back of the flow cell of the extracorporeal circulation (vv-ecmo) circuit.After that, blood leaked from the crack and the extracorporeal circuit stopped.The circuit was replaced urgently.Respiratory and circulatory collapse occurred while extracorporeal circulation stopped (hypoxia and temporary bradycardia occurred).Three days later, the same part of the circuit (the part of the flow sensor of the arterial line) was cracked, which caused a plasma leak of the oxygenator, so the circuit was replaced.Extracorporeal circulation was maintained as of the timing just before the circuit was replaced, but hypoxia occurred during the circuit replacement.After the circuit was replaced, the circulation and respiration recovered by resuming the extracorporeal circulation, but nonetheless hypoxic encephalopathy was concerned due to the continued hypoxemia, and thus hypothermia therapy was performed.Although the direct relationship with the product defect was unknown, the patient died with cerebral hemorrhage complicated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc MN 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc MN 22570 ; MX 22570
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10366502
• MDR Text Key: 201659524
• Report Number: 2184009-2020-00037
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K924529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: CB5P05R8
• Device Catalogue Number: CB5P05R8
• Device Lot Number: 217570725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 07/31/2020; 08/31/2020
• Supplement Dates FDA Received: 08/27/2020; 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• 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): Death
• Patient Age: 6 YR