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 Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the user facility tried plugging the affected pump cable in multiple times, but the issue remained.The manufacturer's service representative confirmed that the connections were all connected but that the power supply had not been turned on.The pump was reassembled and the issue was resolved.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a question mark (?) appeared over the roller pump icon on the central control monitor (ccm).The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed no question mark symbol "?" over the pump icon.The pump functioned as intended throughout the evaluation.The service repair technician (srt) was unable to duplicate the reported complaint.He replaced the pump pod, the pod to lower housing cable and installed a new network interface card (nic) cable as a precaution.The unit operated to the manufacturer's specifications.

Event Description

The clinicians attempted to plug the pump in and out of the network interface card (nic) board a few times, but this did not mitigate the concern.According to the information available, the pump was not functioning correctly and did not have forward flow.The loss of assignment of the six inch roller pump concerned the clinicians enough that they moved the disposable over to another roller pump and continued the surgery without concern.They did not exchange the specific hardware roller pump, but as noted they moved the disposable over to an open roller pump.This incident did not delay the continuation of the surgical procedure, and there was no blood loss or harm associated with the event.

Manufacturer Narrative

Per data log analysis, the log starts on (b)(6) 2018 and it shows that the pump is rebooting over and over."vmot voltage range error" seems to be the cause, always under range at 44 millivolts (mv).This will then cause the "?" on the pump icon as reported.The issue seems to stop on the same day.During additional laboratory analysis of the pump pod and cable, the product surveillance technician (pst) observed the c-23 capacitor of the application board to be open.Reconnection of capacitor c-23 indicated that c-23 is internally shorted which is connection (v-mot 24 volt (v) to ground) and causing the "?" to appear.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: 7732270
• MDR Text Key: 115524706
• Report Number: 1828100-2018-00394
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/28/2018
• Supplement Dates FDA Received: 08/24/2018; 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention