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 Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), the pump was being used as a sucker pump.The user facility removed the tubing but still received an error message.The roller pump was reset by unplugging and reconnecting the power cable but problem remained.The fsr attempted to start the unit without tubing installed but the roller pump never started and would show either one of the following messages; 'pump jam', 'motor error' or 'service pump'.These error messages were only on the roller pump display and did not produce an audible alarm.He installed new roller pump.Data logs were returned to the manufacturer on 01-jun-2018.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the unit displayed a "pump jam" and "motor error" message while there was no tubing installed.As a result, an alternate device was employed.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) could not confirm the reported issue.The roller pump functioned normally throughout the evaluation.Per log analysis on (b)(6) 2018, each time the large roller pump was started it stops with a motor fault, or a belt slip jam status = true.The log confirms the complaint.

Manufacturer Narrative

An additional evaluation was performed to the unit.The product surveillance technician (pst) powered off the pump and removed the pump pod assembly.The pump pod was inspected for any evidence of faulty solder joints or component damage.No damage was noted.In addition, the connector p2 of the digital encoder cable was removed from the pump pod.The pins 1 to 4 from connector p2 were extracted and then each pin to wire connection was inspected.All the pin crimps to wire are accurate and secure.The pump was reassembled and continued to test over a four day period with no errors.The service repair technician (srt) did additional testing and was unable to duplicate the reported complaint.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 unit was returned to the manufacturer on 06-aug-2018 for additional testing.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) was unable to duplicate the reported complaint passing all release testing.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
• MDR Report Key: 7621084
• MDR Text Key: 111857782
• Report Number: 1828100-2018-00318
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180203
• 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,Followup
• Report Date: 10/05/2018

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 08/06/2018; 08/06/2018; 09/14/2018
• Supplement Dates FDA Received: 07/20/2018; 08/14/2018; 08/28/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1