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 Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per the manufacturer's sale representative, when the pump is being primed the tubing is cold and stiff sometimes causing the belt slip alarm.The alarm is intermittent and goes away once the tubing is warmed up when priming.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, there was a belt slip alarm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The field service representative (fsr) installed a loaner pump.The unit operated to the manufacturer's specification.The suspect unit was returned to the manufacturer for evaluation.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint condition.He replaced the drive belt as a precaution and most likely cause of the reported complaint.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Per data log analysis, the complaint indicates the issue occurred on (b)(6) 2018, but there are no log entries for that date.The log does show underspeed (head < demand) 3 times on (b)(6) 2018, 2 times on (b)(6) 2018, and 2 times on (b)(6) 2018.This will cause the belt slip message as reported.It is possible this event is being caused because the pump is over occluded.During laboratory analysis.The product surveillance technician (pst) observed ¿underspeed¿ then ¿beltslip¿ message begin to appear on pump display only when pump occlusion was adjusted to 80 clicks past optimal occlusion (over occluded) tested pump for belt slip error condition with pump jam test fixture and observed pump to generate expected results.

• 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: 7338418
• MDR Text Key: 102461639
• Report Number: 1828100-2018-00127
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: 03/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1