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

Model Number 6379

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00127.During the laboratory evaluation for emdr #1828100-2016-00127, the pst observed after approximately five hours of testing the flow display on the device under test (dut) console had dropped to 2.2 liters per minute (l/min).Speed remained at 2010 revolutions per minute (rpm).The reference flow device remained steady at 4.5 l/min.Approximately 1-1/2 hours later, the flow display had further dropped to 1.7 l/min.The dut console was then moved (picked up and tipped around a bit) which caused the flow reading to go up to around 3.0 l/min.And finally to 4.5 l/min.(original setting) with more physical manipulation of the console.Subsequent agitation/manipulation by the pst of the console, flow sensor, internal cables and circuit boards, and the flow sensor cable at the rear of the console could not duplicate the fluctuation of the flow rate display.Residue was observed on the flow sensor cable connector and the sensor mating connector at the rear of the console.Additional testing using cool spray and a heat gun giving each temperature extreme several minutes to ¿soak¿ into the device while in operation.No significant variation in flow was observed.The device was sent to service for further evaluation.

Event Description

The product surveillance technician (pst) reported that during laboratory evaluation for emdr #1828100-2016-00127, the centrifugal control module displayed erratic flow values.There was no patient involvement.

Manufacturer Narrative

The reported complaint was 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 CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• 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: 5543984
• MDR Text Key: 42430678
• Report Number: 1828100-2016-00229
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• 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: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-01/09/12-005-C
• Patient Sequence Number: 1