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

Model Number 816571

Device Problems Detachment Of Device Component (1104); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The perfusionist has reported this issue previously and is unhappy with the design of the lids and hinges on the roller pump.The field service representative will replace lids once the new style lids are available.

Event Description

It was reported that prior to the use of the device for a cardiopulmonary bypass procedure, the lid fell off of the roller pump.The perfusionist re-installed the lid and used the device for the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per field service representative (fsr), the old style lids and caps were removed and replaced with new style lids add occlusion knob caps on all the roller pumps.The fsr tested operation of the roller pump, but only as to the lid function and cover safety interlock.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• 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: 6490598
• MDR Text Key: 72933133
• Report Number: 1828100-2017-00177
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2010
• 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