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 Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) evaluated the pump and found the device had debris and dust blocking the tachometer on the pump.The fsr cleaned the inside of the device and removed the debris.The device was tested and was found to meet manufacturer's specifications and was returned to use.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, the pump displayed erratic numbers for flow.They had to came off pump to change the pump head.Per clinical review on (b)(6) 2017: per certified clinical perfusionist (ccp), about 5 minutes after the start of cpb, the flow display on the arterial roller pump became erratic with the calculated flow jumping from 5 l/min to 2 min or 0.5 l/min to 9 l/min.According to ccp the actual pump speed and flow rate was not changing, just the calculated flow display was erratic.He stated the pump displayed reset in the message window, but the pump did not stop.Since this occurred during the first minutes of cpb and the aortic cross-clamp had not yet been applied and cardioplegic arrest had not been induced, the team elected to wean the patient off cpb and change out this roller pump as they were not comfortable with the behavior of the pump.The patient was weaned successfully and was hemodynamically stable.The arterial line was clamped and the tubing was removed from the pump.The pump was removed from the base and a back-up pump was placed on the base and the tubing was placed in this new pump.Occlusion was checked and cpb was re-initiated.The time off cpb was about 2 minutes and so the delay in the surgical procedure was 2 minutes.There were no other issues the remainder of the procedure.The case was completed successfully, with a 2 minute delay in the surgical procedure as the arterial pump was changed out.There was no associated blood loss and no harm was observed.

• 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: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6361316
• MDR Text Key: 68757874
• Report Number: 1828100-2017-00096
• 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
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2007
• 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
• Patient Outcome(s): Required Intervention