MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The system-1 (aps1) is not used and kept in the hallway outside the operating rooms and not plugged into alternating current (a/c) outlet.The fsr performed the nfc, left system-1 charging overnight and when fsr returned, the front panel light emitting diode (led) was yellow.The total nominal available capacity (tnac) was at 18.0000 but when fsr removed the aps1 from a/c power, the system shut down.The batteries were last replaced on (b)(6) 2014 by the fsr.The last preventive maintenance (pm) performed by the fsr was (b)(6) 2014.The hospital has denied all requests for semi-annual preventive maintenance by the manufacturer, they opted to go with a third party.This aps1 is currently being maintained by (b)(4) (uncertified third party biomedical engineer (biomed).No batteries will be returned to the manufacturer for evaluation.

Event Description

It was reported that during the use of the device for a notice of field correction (nfc), the field service representative (fsr) discovered that the batteries were dead.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per follow-up with the field service representative (fsr), the customer does not use this device and does not want service at this time.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: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5619729
• MDR Text Key: 44028869
• Report Number: 1828100-2016-00298
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-03/13/12-004-C
• Patient Sequence Number: 1