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 Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

As per the perfusionist, the tubing was in the roller head when occlusion was set.Occlusion was set by clamping the 1/4" tubing on the inlet side.The roller head was turned up and occlusion tightened until the tubing collapsed from negative pressure.Then the revolutions per minute (rpm) turned to zero, where the tubing remained collapsed.Occlusion slowly loosened until the tubing regained its original shaped.Rpms turned back up to collapse the tubing and adjustments were made until tubing continued to slowly regain its shape.The field service representative (fsr) verified the reported complaint.He replaced the roller pump.The unit operated to the manufacturer's specifications.The suspect unit was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pump was not holding its occlusion.The occluder was manually tightened throughout the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the system was set up without issue for a case on (b)(6) 2019.The perfusionist set his occlusion per hospital protocol for his roller pump in the suction position.He uses traditional 1/4 inch polyvinyl chloride (pvc) tubing for his suction.Occasionally during the cpb procedure, he would lose occlusion on this roller pump, and every few minutes he had to readjust and tighten the occlusion.He stated that the roller head had a very slight visual wobble to it when it was in use.Additionally, he stated that the roller pump did not make any sort of noise, and did not indicate to him with a visual or audible message of a functional failure of the roller pump.The team did not exchange the pump during the procedure.There was no delay in the continuation of the surgical procedure.There was no blood loss or harm associated with the incident.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the pump to un-occlude when it was occluded.It was determine that the collar cam block assembly, a component within the pump guts, was the cause of the problem.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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: 8302677
• MDR Text Key: 136321966
• Report Number: 1828100-2019-00057
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180725
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1