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 Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per the fsr, channel 3 on the network interface card (nic) board is defective.The customer did not want the nic board replaced because there are eight other available channels.The roller pump cable was moved to another channel and the roller pump 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.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a question mark appeared on a roller pump that was in the sucker one position on the perfusion screen.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: during a cpb procedure, the four inch roller pump that was the sucker pump for the procedure lost connectivity to the network and a question mark (?) appeared on the perfusion screen.The perfusionist was able to still use the pump by restarting it at the local display and adjusting the flow at the local display.The pump was used for the remainder of the procedure.The field service representative (fsr) has investigated it and the cause is the cable, and that will be replaced in a timely manner.The incident did not delay the surgical procedure and the patient was weaned from cpb without issue.There was no related blood loss nor harm due to the concern.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) the reported complaint was corroborated but not duplicated.The likely cause was former liquid ingress that had gotten beneath components of the network interface card (nic) printed circuit board (pcb).The ingress has since dried, leaving residue and causing corrosion in various areas of the pcb.The device under test was functional during evaluation.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

The reported complaint was confirmed.The field service representative (fsr) returned to the user facility and replaced the network interface card (nic) board.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.

• 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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6963106
• MDR Text Key: 90673079
• Report Number: 1828100-2017-00481
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2018

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: 06/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 04/06/2018; 07/19/2018
• Supplement Dates FDA Received: 04/11/2018; 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2007
• 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