MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER

Model Number 16402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the roller head was skipping.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The field service representative (fsr) could not verify the pump to be skipping because the roller pump gave an overspeed 1 error when the motor was started.Troubleshooting found the pump driver printed circuit board assembly (pcba) to be the source of the problem.A failing pump driver pcba can cause pump to skip.The fsr also found that the fan that cools the pump driver pcba was not turning but would turn when touched.A failing cooling fan can cause the pump driver pcba to fail.The fsr replaced the pump driver pcba.The unit operated to the manufacturer's specifications.The suspect part will be returned to manufacturer for further testing.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) inspected the circuit board and found overheating on the connector where the pump's motor was attached.The pst attached the board to a lab 8k pump test fixture and the poor connection to the motor caused the pump's motor to stop and start randomly.The pst connected the returned fan to a power supply and fan did not rotate when 12 volts was applied.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: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
• 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: 6438640
• MDR Text Key: 71221041
• Report Number: 1828100-2017-00148
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/1999
• 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