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

Model Number 816571

Device Problems Low Audible Alarm (1016); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was a belt slip on the cardioplegia roller pump.The device was not changed out, as the pump was used in the case and functioned as needed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2016: according to the perfusionist (ccp), during cardiopulmonary bypass, the cardioplegia (cpg) pump would slow down, almost to a stop, and then would speed back up.The ccp said that with the pump speed slow down, the pump would show a "belt slip" error message accompanied by an audible alarm.This issue occurred during active cardioplegia delivery.The ccp did not manually hand crank, but she did increase the speed of the pump to get through the slow down.She mentioned that she attempted to adjust the occlusion, but it did not help.Additionally, she added that the occlusion was set in the normal fashion and set to the same point as always.The ccp continued to use the pump for the remainder of the case and there was no impact to the patient as a result.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

During the laboratory evaluation, the reported issue was not duplicated.The product surveillance technician (pst) observed ¿underspeed¿ message then a ¿beltslip¿ message begin to appear on roller pump display only when pump occlusion was adjusted to 90 clicks past optimal occlusion.The pst tested the roller pump for "belt slip" error condition with the pump jam test fixture and observed the roller pump to generate expected results per procedure of the service bulletin.The pst inspected drive belt, drive belt tensioner, and encoder with no damage or wear observed.He inspected for evidence of oil contamination and no evidence of oil contamination observed.Inspected all internal cabling and connections and observed no loose connections or damaged cabling.The pst reassembled the roller pump and tested for two hours at optimal occlusion and observed normal operation.The device was sent to service for further testing.

Manufacturer Narrative

The reported complaint was confirmed.Per log analysis, the complaint indicates the belt slip error occurred on 24-may-2016 but no events were logged on that date that would cause belt slip to be displayed.On 23-may-2016 there were four "underspeed (head < demand)" events and one underspeed (belt slip) event logged.These events could be normal if the pump was over occluded, but there is no way to tell from the log if that was the case.The product will be brought to manufacturers 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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5726703
• MDR Text Key: 47496255
• Report Number: 1828100-2016-00447
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• 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: 06/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2010
• 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