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

Model Number 801763

Device Problems Failure to Run on Battery (1466); Charging Problem (2892)

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

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, when the perfusionist (ccp) unplugged the system-1 from a/c power, the system shut down and did not switch to battery power.Battery indicators are full.As a result, an alternate system was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the user facility's biomedical engineer (biomed), the batteries state that they are fully charged.The second perfusionist said that the batteries are showing 225 minutes.When removed from a/c power at 08:52 am today ((b)(6) 2014), the back-up battery functioned as expected.Just prior to the case, at 12:15 pm, a/c power was removed and the system did not go onto back up battery power.This issue was duplicated by their biomed.Per the perfusionist, on (b)(6) 2014 he unplugged from a/c power from the system-1 and battery backup worked as expected.

• 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: 3904479
• MDR Text Key: 21876991
• Report Number: 1828100-2014-00397
• 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: 05/06/2014

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: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2005
• 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