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 801041

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the pumps display would intermittently go blank.The pump was controlled through the central control monitor (ccm).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2017, the heart lung machine (hlm) was set up and primed without issue.Shortly after initiation of cpb, the roller pump in the sucker position's local display started flickering.The local display would go blank intermittently, and then come back on, and go back out again.The perfusionist on the procedure opted to use the ccm to visually see the flow of the sucker pump, and to adjust the flow.The local knob control was still in usable form.The roller pump was not changed out during the case, but they exchanged it after the procedure was finished.The incident did not delay the surgical procedure.The was no harm nor blood loss associated with the event.

Manufacturer Narrative

The reported complaint could not be confirmed.The field service representative (fsr) was unable to duplicate the complaint.He replaced the pump display assembly as a precaution.The unit operated to the manufacturer's specifications.Per data log analysis, on 19-dec-2017 there are no indications of a problem in the log file.It is possible the display blanked without logging anything.Normally this is a small display assembly issue, or a connection to the small display assembly.During laboratory analysis, the product surveillance technician (pst) observed the display assembly to function normally throughout the evaluation with no loss of display.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: 7187395
• MDR Text Key: 97865323
• Report Number: 1828100-2018-00020
• 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
• Report Date: 04/06/2018

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: 03/16/2018
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-06/05/2007-011-C
• Patient Sequence Number: 1