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 Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pump control unit error was over speeding.No other details regarding the nature of this event were provided.Diligence attempts are still ongoing in obtaining event information.

Event Description

An alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: this occurred during set-up.An overspeed error was observed with this pump serving as a sucker.No patient exposure as it was during set-up and the pump was not used for the procedure.

Manufacturer Narrative

(b)(4).The field service representative (fsr) verified that the roller pump displayed over speed 1 error.He found that the pump driver printed circuit board assembly (pcba) was the source of the problem.The pump driver pcba was replaced.The unit operates to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) installed the printed circuit board (pcb) onto a lab 8k pump test fixture.The pst operated the test fixture for 48 hours with no overspeed occurring.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6540096
• MDR Text Key: 74419334
• Report Number: 1828100-2017-00211
• 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,Followup,Followup,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• 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: 08/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2004
• 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