MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 195240

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the level sensor pads are not sticking.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Originally the customer had four cases.The customer has continued to use this lot of level sensor pads until a new lot has been received.

Manufacturer Narrative

Per follow-up with the manufacturer's sales representative, the customer attaches the level sensor to the sensor pad within a minute after placing the pad on the reservoir.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4898279
• MDR Text Key: 20153721
• Report Number: 1828100-2015-00554
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Device Lot Number: 158254
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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