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

Model Number 6379

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

The field service rep (fsr) reported that during preventative maintenance (pm) of the device, there was a blown fuse in the power entry module causing the batteries to discharge as they were not able to be charged.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) replaced the fuse.The batteries were allowed to fully charge and fsr checked with the user facility's biomedical engineer (biomed) to confirm status of batteries.The biomed stated the charging light remained steady.The fsr replaced batteries and preventive maintenance was completed.The unit operated to manufacturer specifications and was returned to clinical use.During laboratory evaluation, both batteries fail to meet the minimum specification for conductance, even after fully charging.The product surveillance technician (pst) noted no damage or physical anomalies observed upon receipt of batteries.The batteries measured 13.1 and 13.0 volts direct current (vdc) upon receipt (13.2 vdc or higher is typical for batteries of this type having a full or near-full charge).Conductance measurements were 17 siemens (s) and 16s respectively (failing).Minimum conductance specification is 75s for this battery type.The pst attached device under test (dut) batteries into lab-use only (luo) delphin battery (charger) and powered on.After charging for three hours, the charger light emitting diode (led) was flickering, which indicates full charge has been reached.

• 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: 4844523
• MDR Text Key: 5872012
• Report Number: 1828100-2015-00482
• 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: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

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: Other
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-01/09/12-005-C
• Patient Sequence Number: 1