MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801041

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, during the thoracoabdominal part of surgery, the unit was used as a main pump and disposable tubing was used to deliver the blood to the superior mesenteric artery (sma) with the separated circuit.No problem was identified at the start of the surgery, including during priming of the device, but the blood leaked from the tubing into the large roller pump about 40 minutes after using the separated circuit.The roller pump was filled with blood and the blood was almost overflowing.The flow rate in the main pump was around 3.3-3.8 liters per minute (l/min) and in the separated circuit was 200 ml.The reservoir level was also lowered so that the main pump temporarily stopped by the heart lung machine (hlm) safety control.The main pump was recovered in 20 seconds and another micro-physiological system (mps) was used.The root cause of the blood leakage was tubing damage but it occurred in the roller pump with the alleged possibility that the roller pump could have caused the damage.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the tubing that was inside the roller pump had ruptured and had leaked blood.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was 400 milliliters (ml) of blood loss.There was no delay, nor adverse consequences to the patient.

Event Description

Per clinical review: on 04aug2022, the team experienced a problem with their heart lung machine (hlm) while on cardiopulmonary bypass (cpb) described as 'blood leakage'.It appears that a secondary circuit was being used for isolated superior mesenteric artery (sma) perfusion during a thoracoabdominal procedure, and the tubing in the pump raceway ruptured, leading to approximately 400 milliliters (ml) blood loss.This was changed out to a micro-physiological (mps) system and the procedure was completed successfully, with no delay reported.It should be noted that a tubing rupture in the pump raceway can be caused by several factors: defect in the tubing itself, damage to the tubing from external or internal sources, or defect in the pump mechanism.

Manufacturer Narrative

The reported complaint was confirmed.The unit was end of service life (eosl) and the user decided not to return the unit to the manufacturer so no further evaluation or root cause analysis could be performed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15311430
• MDR Text Key: 305504301
• Report Number: 1828100-2022-00312
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1