MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1

Model Number 801041

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the roller pump display went in and out (blank).The user was still able to control using central control monitor (ccm) but changed out unit before case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was not confirmed.During laboratory analysis, the reported complaint could not be duplicated.The product surveillance technician (pst) observed no blanking out of the display throughout testion conditions.Customer product was sent to service to be brought to manufacturers specifications before being returned to clinical use.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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5948940
• MDR Text Key: 54679799
• Report Number: 1828100-2016-00615
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• 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
• Report Date: 10/14/2016

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: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2011
• 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