MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

Model Number 816571

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there were several occasions of the pump jamming and they had difficulty getting the roller pump re-started.The surgical procedure was completed successfully.There was a delay of three minutes.There was no blood loss nor adverse consequences to the patient.The team uses an 8:1 tubing pack for the delivery of cardioplegia.During a case on the (b)(6), it was noted that possibly the perfusionist had not loaded the tubing set as it needed to be and that it may have bounded up a little bit in the roller raceway and caused a pump jam situation.The perfusionist asked the surgeon to take off the cross clamp while he troubleshot the situation.There was a three minute delay (patient was still on bypass with full support) while the team mitigated the issue, and rearranged the tubing within the raceway to not cause a pump jam situation the remainder of the case.The patient received the correct dosage of cardioplegia for the induction dose, along with the subsequent doses, for the roller pump worked well the remainder of the procedure.The team has put in some additional protocols to mitigate the possibility of this problem occurring in the future, which is allowing the tubing and roller pump to "warm up" prior to initiation of placement of the cross-clamp, and being aware of the usage of the tubing clamp guides when loading the 8:1 set in the roller raceway.The incident did not cause either blood loss or harm to the patient.

Manufacturer Narrative

The reported complaint was confirmed with information provided by the manufacturer's clinical specialist.Per the manufacturer's clinical team, the user facility's process of setting up the 8:1 tubing set in their roller pump was discussed, and the different techniques some of the team uses to load the tubing.They discussed the process of allowing the pump to run continuously while the arterial pump is running, after the conclusion of the priming process, and prior to the initiation of cardiopulmonary bypass (cpb).The team has seen both bunching up of the tubing on the outlet side of the roller pump and the 8:1 tubing rolling in on itself on the outlet side of the roller pump.On the outlet side, post the tubing guide clamps, the team has tie-banded the tubing to mitigate the issue.Additionally, some of the staff has tie-banded the inlet side of the tubing proximal to the tubing guide clamps.The team has set occlusion to the smaller tubing on their 8:1 tubing set.It was discussed and decided with the perfusion team to trial a smaller roller pump in the cardioplegia location to see if this helps mediate the pump jam issue.By using a smaller roller pump, the location of the flexible y's on their tubing set would be in a different location, further from the raceway.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8151997
• MDR Text Key: 130658944
• Report Number: 1828100-2018-00627
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2019

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 Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 01/30/2019
• Supplement Dates FDA Received: 12/20/2018; 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention