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

Model Number 16402

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to verify the reported issue.He checked both fans to make sure they were okay, cleaned the roller pump motor brushes, and checked the pump calibrations and operation.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump turned in a jerking motion.As a result, an alternate device was employed.No other details regarding the nature of this event were provided.

Event Description

Per clinical review: on (b)(6) 2019, the team noticed a jerky rotation of their roller pump a few minutes prior to termination of the cardiopulmonary bypass (cpb) procedure.The roller pump in the arterial position was set up and primed with a 3/8 inch arterial raceway tubing boot.The occlusion was set according to hospital protocol.The jerky motion was noticed when they were at a lower speed when coming off bypass.The perfusion team noticed a knocking or thumping noise earlier in the procedure at a higher flow rate, but stated it was not evident that these two were related.The motion was it would spin as normal then kind of shimmy back and forth, then keep forward flow going.The team exchanged the roller pump after the patient was stable and off cpb.There was no harm or blood loss associated with the event.There was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

Updated blocks: b5 and h6.

Manufacturer Narrative

Updated block: h6.The reported complaint could not be confirmed.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8744008
• MDR Text Key: 149506164
• Report Number: 1828100-2019-00346
• 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,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1