MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGUAL SYSTEM; CAPIOX CENTRIFUGAL DRIVE MOTOR

Model Number 811474

Device Problems Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

During semi-annual preventive maintenance (pm), the service repair technician (srt) reported that there was a "pump jam" error message on the centrifugal drive motor at maximum revolutions per minute (rpms).There was no pt involvement.

Manufacturer Narrative

Pma/510(k): export only.Evaluation is in progress, but not yet concluded.This complaint is related to mdr #: 1828100-2015-00427.The unit was never used prior to svc performing the pm.The manufacturing laboratory at (b)(6) believes this to be an "out of box" failure.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) was able to duplicate the complaint.There was no signs of damage observed during visual inspection.When the pst connected the capiox drive motor to lab-use only (luo) control module, system-1 power supply and 36 inches capiox water loop and increased speed on pump module to maximum; he observed a "pump jam" error message at approximately 2660 revolutions per minute (rpm).The pst connected oscilloscope to pin 1 (p1) of pump pod, restarted pump and adjusted speed to 2650 rpm.The current drawn was 6.08 amps.Current above 6.5 amps causes a motor over-current event.But, the capiox motor was failing before it draws the 6.5 amps threshold.The pst disconnected capiox water loop from drive motor, started pump and increased speed on pump module to maximum and observed drive motor to reach 3000 rpm with no "pump jam" message.When the capiox water loop was shortened to 24 inches, drive motor stopped and display "stop: pump jam" message on pump module when the pump reaches approximately 2640 rpm.The pump speed was adjusted to 2630 rpms, the current drawn was 6.07 amps.When the capiox water loop was lengthened to 60 inches, the drive motor was observed to run at 2960 rpm with no pump jam message and the current drawn was 5.65 amps.When luo motor was tested with 36 inch capiox water loop, the drive motor was observed to run at maximum speed of 2700 rpm with no pump jam message and the current drawn was 4.7 amps.The luo motor was observed to run at maximum speed with no pump jam error message when 25 and 12 inches long tubing were attached.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 CENTRIFUGUAL SYSTEM
• Type of Device: CAPIOX CENTRIFUGAL DRIVE MOTOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4804494
• MDR Text Key: 20755800
• Report Number: 1828100-2015-00426
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/04/2015

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: 811474
• Device Catalogue Number: 811474
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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