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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This unit is a test unit and not used clinically.The fsr installed a new dual tach printed circuit board (pcb).The unit operated to the manufacturer's specifications.The defective part was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #1828100-2017-00509.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the roller pump displayed a "belt slip" error message.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) installed the dual tach board into an 8k pump test fixture.The pst powered on the pump and started rotations of the pump.No belt slip errors occurred.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
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7010101
• MDR Text Key: 92617781
• Report Number: 1828100-2017-00510
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/1998
• 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