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 Device Displays Incorrect Message (2591)

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

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the reported complaint.He found the optical sensors on the dual tachometer board were coated with white dust.He replaced the dual tachometer board.The unit operated to the manufacturer specifications.The suspect part was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #1828100-2018-00262.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a "belt slip" error was displayed.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed residue found on the opto-switches likely from the pumps encoder wheel causing the belt slip errors.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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

Additional information was received that the surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018, the roller pump gave the perfusionist a belt slip error, along with a thumping noise.The perfusionist opted to turn off the roller pump temporarily and then restart it.This was an ancillary roller pump so she was able to do this without concern.The thumping continued, but the belt slip error resolved itself and she was able to use the roller pump for the remainder of the procedure without a functional issue.The incident did not delay the surgical procedure, and there was no harm or blood loss associated with the occurrence.

• 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: 7550487
• MDR Text Key: 109494634
• Report Number: 1828100-2018-00281
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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: 05/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1