MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM-1

Model Number 801763

Device Problems Failure to Run on Battery (1466); Power Conditioning Problem (1474); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass procedure, the hosp experienced a power outage.The system-1 shut down and never went on battery.The power light emitting diode (led) was yellow on the front panel of the unit.As a result, an alternate system was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

During the laboratory eval, the product surveillance tech (pst) stated the batteries were received in a severely depleted condition that is consistent with batteries having not been routinely exercised or kept charged.Due to the poor condition, no attempt to perform further testing (recharging) was performed.Permanent degradation in battery capacity has occurred.No physical damage or other anomalies observed upon receipt of batteries.The batteries measured 6.6 and 1.0 volts direct current (vdc) upon receipt using a standard high impedance multimeter.The readings both went to zero vdc when measured using the conductance meter's voltage function.The light loading of this meter was enough to draw the voltages to zero.This indicates severe depletion that is consistent with lack of battery exercise and/or regular charging maintenance and corroborates the reported complaint.

Manufacturer Narrative

The reported complaint was confirmed.The batteries had not been replaced since (b)(6) 2012 and were past the two year preventive maintenance (pm) mark when they should have been replaced.The field service representative (fsr) performed pm.With new batteries installed, the fsr could not reproduce the battery issue of "not switching over to battery." the unit operated to the mfr's specifications and was returned to clinical use.No additional action wil be taken at this time.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM-1
• 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: 4745293
• MDR Text Key: 5771778
• Report Number: 1828100-2015-00347
• 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,Followup
• Report Date: 04/09/2015

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: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 04/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• 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