MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR APS1

Model Number 816571

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The field service representative (fsr) discovered the issue while troubleshooting.He replaced the 6" pump module, updated its software to version 1.40 and reprogrammed new address to work in customer's perfusion configuration.The roller pump operated to manufacturer's specifications.The suspect device was returned to the manufacturer for evaluation.

Event Description

It was reported that during the use of the device for a non-clinical activity, the pump intermittently would not transfer events to the central control monitor (ccm) instead it would display "no events" message.The pump rotations display would not update but would just show the previous reading.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) connected the pump software module to a system 1 simulator and it powered normally.Then using a central control monitor (ccm), the service screen was opened and the permanent address of the module was confirmed.The log files were downloaded successfully and stored to the designated directory with no errors.The device under test (dut) was power cycled after 30 minutes and the viewing of the device history (log) was retested within the service screen.The history (log) file was viewed successfully on several attempts over several hours.No errors on ccm displayed.The pst tested the device for three days and could not duplicate the reported complaint condition.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 FOR APS1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6399509
• MDR Text Key: 70061792
• Report Number: 1828100-2017-00126
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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: Other
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2008
• 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