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

Model Number 801041

Device Problem Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the pump stopped.No other details regarding the nature of this event were provided.

Event Description

Per clinical review: no additional information was available at the time of the clinical review.The team had an incident with the roller pump.The date of occurrence was not noted.It is not known if the incident occurred during the cardiopulmonary bypass (cpb) procedure, before the procedure started, or during non clinical activity.Because of the lack of available information, the hazards will be associate as a worse case situation, which would be if the incident occurred on bypass in the arterial pump position.The team had a roller pump stop.It is unknown what mitigation occurred to fix the issue.It is unknown if a delay occurred because of the pump stop.Additionally it is unknown what type of tubing is traditionally used in the clinical setting at this institution.Additional information regarding the surgical procedure and the patients outcome associated with this event is not known.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence for part return and additional information was unsuccessful.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8142895
• MDR Text Key: 129896305
• Report Number: 1828100-2018-00620
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1