MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM

Model Number 9490

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the battery was not holding a charge.The customer noticed a red battery light so she unplugged the unit and it died.They plugged the unit in over the weekend and the unit did not charge.There was no case involved.Issue was noticed when they were checking the units.There was no patient involvement.

Manufacturer Narrative

Per the customer, previously the battery did switch over when tested.The switch was in the disconnect position during charging.They did not get an "on battery" alert message.The battery backup is always plugged into the control module and the battery was fully charged prior to discovered failure.The charge indicator light illuminated when alternating current (a/c) power was on.The charge indicator light initially comes on and then stopped working.The field service representative (fsr) will determine what parts will be returned when he visits the user facility for their next preventive maintenance (pm) in (b)(6).

Manufacturer Narrative

The field service representative (fsr) verified the report source reported complaint.The fsr replaced the batteries in the centrifugal battery hack-up and completed preventive maintenance (pm).The unit operated to manufacturer (b)(4) foreign specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.During the laboratory evaluation the reported complaint was duplicated.The returned batteries showed that the battery pair to be out of performance specifications.One of the two batteries does not properly accept charging.No damage or physical anomalies observed upon receipt of batteries.Batteries measured 12.8 volts direct current (vdc) and 7.8 vdc upon receipt (11.5 vdc or higher is typical for discharged batteries of this type.).Conductance measurement of the first battery was 98 siemens (s) but were not available for the second battery, due to the low voltage (the conductance meter requires approximately 11.8 vdc to obtain this reading).The minimum conductance rating is 75s for this battery.The product surveillance technician (pst) attached the batteries to lab use only (luo) dolphin battery charger and powered on.Initially the green charging light emitting diode (led) was illuminated steady as designed, but went dark within the first minute of operation.This duplicate what was reported regarding the charging led.After charging for 24 hours, the battery voltage readings were similar (12.9 and 8.8 vdc respectively).This demonstrates that the second battery will not properly charge and corroborates the reported complaint.The first battery's conductance remained at 98s which passes the minimum requirement of 215s.With a/c power removed and the "connect" switch closed, the luo meter indicated very low battery capacity.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.Service history shows that batteries were last replaced in (b)(6) 2012.It suggests that they were within their life span of three years when the complaint was reported.No additional action will be taken at this time.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 7346634145
• MDR Report Key: 4768626
• MDR Text Key: 5776016
• Report Number: 1828100-2015-00392
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2015

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: 9490
• Device Catalogue Number: 9490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2015; 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-06/29/12-020-C
• Patient Sequence Number: 1