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

Model Number 16402

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's biomedical technician, the problem occurred sometime in early (b)(6) 2019, but he does not know which date exactly.He determined that the speed pot assembly was the issue.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump did not start rotating when set at a low speed.Once the speed was increased, the roller pump would immediately jump to the set speed.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

The reported complaint was confirmed.The user facility's biomedical technician who is trained by the manufacturer has replaced the speed pot assembly.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: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8569904
• MDR Text Key: 145628318
• Report Number: 1828100-2019-00204
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1