MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 6379

Device Problem Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) went to site and found battery cracked.Per follow-up with the fsr: the internal batteries were last replaced (b)(6) 2014, this ccm is not used frequently, unit is plugged in all the time, the battery was not switching over when they lost alternating current (a/c) power, the switch was in the "connect" position, there was no ¿on battery¿ alert message, the a/c power connection in the back was secure and there was no visible corrosion.

Event Description

It was reported that during the use of the device for a non-clinical activity (found during routine checks procedure the user does monthly), the batteries were not charging on the centrifugal control module (ccm).There was no charging light illuminated.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, the reported complaint was corroborated.Per the product surveillance technician (pst) both batteries are severely discharged.Both batteries have deformation (cracking) at the positive terminals (cause is undetermined).Batteries both measured approximately 11.4 volts direct current (vdc) upon receipt, using a standard multimeter.Due to the cracking at the battery terminals, no attempt to charge was made.Conductance measurements were not available for either battery due to their low voltages.The conductance meter requires approximately 11.75 vdc to obtain this reading.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 field service representative (fsr) removed the suspect batteries and installed new batteries in the centrifugal control module.The fsr performed a release test and no failures noted.The unit operated to manufacturer specifications and was returned to clinical use.The batteries were within their three years of life span when the complaint was reported.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: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5761536
• MDR Text Key: 48542759
• Report Number: 1828100-2016-00474
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2016

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: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/02/2016; 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2003
• 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