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

Model Number 9490

Device Problem Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the delphin batteries used as backup for their system-1's were not holding a battery charge in the centrifugal system.There was no patient involvement.

Manufacturer Narrative

The fsr replaced the batteries and completed a release test.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.The reported complaint was confirmed.Per the laboratory evaluation, one of the two batteries will not properly charge or support a load.Conductance measurements were not available for the first battery initially, due to the low voltage.The second battery's conductance value measured 67, minimum requirement is over (b)(4) siemens.Service history shows the batteries were within their service life and were last replaced on 05/31/2012.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 CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• 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: 4294323
• MDR Text Key: 5197455
• Report Number: 1828100-2014-01016
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9490
• Device Catalogue Number: 9490
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• 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