MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000

Model Number 16402

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the field service representative (fsr) replaced a couple of circuit boards and that seems to have resolved the reported problem.The suspect parts will be returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump does not display the tubing size or the flow.The device was not changed out, as they continued to use for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on 15-sep-2015: according to the lead perfusionist (ccp), the issue was noticed during cardiopulmonary bypass that the roller pump would intermittently not display the tubing size and flow.They continued to use the pump for the remainder of the case, but the flow was unknown.There was no impact to the patient as a result of the missing data.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, failure of the driver/power board was confirmed.The returned display and central processing unit (cpu) boards performed to and met all specifications.The product surveillance technician (pst) was not able to locate the defective component on the driver/power board.The pst visually inspected the returned boards with nothing observed that would cause failure.No additional action will be taken at this time.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Additional part received on 6-oct-2015 for further evaluation.This complaint is related to mdr #1828100-2015-00887.The field service representative (fsr) tried to repair the roller pump in the field.The fsr replaced two circuit boards most likely to cause this issue (this complaint) but the issue was seen again (refer to mdr #1828100-2015-00887).This is an intermittent problem since the roller pump was working fine when the fsr tested it after replacing the two circuit boards.The fsr returned to replace another circuit board.The fsr ordered a power supply/driver board and installed the new board and tested operation satisfactory.The unit operated to manufacturer specifications and was returned to clinical use.The suspect parts were returned to the manufacturer for further evaluation.

• Brand Name: SARNS 8000 PERFUSION SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5126277
• MDR Text Key: 27672882
• Report Number: 1828100-2015-00840
• Device Sequence Number: 1
• Product Code: DWA
• 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: Followup,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: 10/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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