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

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the system was set-up in the pump room, was left on, when they unplugged the system to move it, the system went dead.As a result, an alternate device was employed.The system was removed from service.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The field service engineer (fsr) ordered batteries as a precaution.The fsr asked the customer to charge the batteries over night.Upon arrival to the user facility, the last measured discharge (lmd) was showing 180/10 18.0 amp hours (ah) and total nominal available capacity (tnac) was showing 18.0000.The fsr replaced the batteries, downloaded power manager and system logs and tested the system.The unit operated to the mfr's specs and was returned to clinical use.The suspect batteries we returned to the mfr for further eval.The reported complaint was duplicated during lab eval.No anomalies observed upon receipt of the batteries.The batteries measured 10.7 and 10.5 volts direct current (vdc) upon receipt (no lead), 11.4vdc is typical for a discharged battery in good condition and 13.2vdc is typical for a battery having a near full charge.No conductance readings were available due to the low battery voltage.The product surveillance tech (pst) attached the device under test (dut) batteries to the pmb platter using a lab battery cable and powered on.The batteries were allowed to charge for seven hours (recommended recharging from full depletion is 13 hours).An interim measurement of the battery voltage of 11.3 and 6.6 vdc respectively, revealed that the pair was not properly accepting charge.This corroborates the reported complaint.

Manufacturer Narrative

The reported complaint was confirmed.Log analysis and lab evaluation corroborate the issue, batteries would not accept charging.Diligence attempts were unsuccessful in obtaining answers to script questions and the outcome of the surgery.No additional action will be taken at this time.

• 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: 4922419
• MDR Text Key: 6050690
• Report Number: 1828100-2015-00579
• 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,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• 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: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• 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