MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. 6 INCH ROLLER PUMP FOR ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 801041

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to mdr #1828100-2015-01046.On (b)(6) 2015, the user noticed that the pump stopped during a case (refer to mdr #1828100-2015-01046).There was no error displayed so the user thought it could be erroneous operation of the switch.Therefore, the user continued using it and the surgery was completed.On (b)(6) 2015, no problem was confirmed with half-day continuous operation of the pump (check-up).Because there was no problem with the pump on (b)(6) 2015, the roller pump was used for an emergency surgery on (b)(6) 2015 (this complaint).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump stopped suddenly.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review on 17-dec-2015: this roller pump was being used for suction.Less than 30 minutes into cpb, this roller pump went to 0 speed.It did not go to the stop mode.There was no messaging (audible or visual) that indicated a cause or reason to go to 0 speed.The user was able to turn the speed back to previous setting within 10 seconds.There were no more issues the remainder of this procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During the laboratory evaluation, the reported issue was not duplicated.The product surveillance technician (pst) observed no disconnected or loose cables and the internal cavity was free of debris.The pst set clock-wise (cw) (reverse pumping) rotation.He ran the roller pump four hours with 3/8¿ tubing at optimal occlusion and 205 revolutions per minute (rpm).The pst reduced speed to 100 rpm overnight, and no problem found.While running, the device under test (dut) pump was picked up and turned in all directions and shaken.The speed knob was agitated and the speed was decreased to about 50 rpm then increased to 150 rpm, again no problem found.The pst reversed direction (to counter clock-wise [ccw]) and ran for additional ten minutes, no problem found.He partially reassembled dut and setup to run in ccw direction on system-1 (aps1) base at 3 liters per minute (l/min), near optimal occlusion on 3/8¿ tubing, ran over 96 hours with no problems.Repowered the dut while opened, using an aps1 simulator and agitated cabling and printed circuit boards (pcbs) while rotating ccw with no tubing installed.He applied gradual heat to pcbs using heat gun, up to approximately 50 degrees celsius.The pump ran approximately 3 minutes at the highest temperature applied, no problem found.The pst powered off, reassembled enclosure and placed in cold chamber at 10 degrees celsius for 20 hours.He removed the pump from cold soaking and immediately setup dut in a perfusion screen running cw at 5.2 l/min, slightly over-occluded, ran for 3 hours with no problem found.The pst changed to standard ccw rotation at 5 l/min.With the same ¿heavy¿ occlusion, ran for another 3 hours with no problem found.He reduced speed to 3 l/min, removed occlusion and ran another 24 hours, no problem found.The roller pump was sent to service for further evaluation.

Manufacturer Narrative

The reported complaint was not confirmed.Data log analysis found that the pump was not used on the date indicated, nor was a failure or indication of one recorded in the log during the few days before and after the reported date of occurrence.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: 6 INCH ROLLER PUMP FOR ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5315330
• MDR Text Key: 34588318
• Report Number: 1828100-2015-01047
• Device Sequence Number: 1
• Product Code: DWB
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2016; 03/15/2016; 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1