MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (ROLLER PUMP)

Model Number 801041

Device Problem Naturally Worn (2988)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the speed knob on the roller pump spun too easy.The device was not changed out, as the worn apm seal did not affect functionality of the roller pump, so customer continued to use.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

Per the field service representative (fsr), this is a wear issue of the arm seal.Fsr installed a new apm seal to resolve reported issue.He also downloaded the data logs for evaluation.The unit operated to manufacturer specifications and was returned to clinical use.The suspect apm seal was returned to the manufacturer for further evaluation.The reported complaint was confirmed.Replacement of seal provided increased resistance.There is no specification for resistance.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: APS 1 (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3869949
• MDR Text Key: 4506598
• Report Number: 1828100-2014-00289
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• 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
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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