MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER RYPE)

Model Number 16402

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

The prod surveillance tech (pst) reported that during routine testing of the device at the svc ctr, that one roller did not spin freely, but sticks with only minimal rotation, approximately 1/8 of its rotation.The pst did not force this roller by hand to attempt freeing it.There was no pt involvement.

Manufacturer Narrative

Customer has new biomedical group starting and they will check device before calling in for svc.At this time, the customer is just reporting failure.Per the field svc rep (fsr), the unit initially powerup to spec and ran all modes of operation with no indication of failure.The unit was powered down and up four or five times without fail.On the six or seventh time, the unit failed to go through its normal power up routine and the control panel would indicate no power and failure.After the power failure to the control panel, the fsr found that by resetting the printed circuit (pc) boards in the card rack, the unit would power on to normal state and all modes of operation worked correctly.The fsr proceeded to turn the unit off and on a half dozen times without further incident.The fsr performed preventive maintenance (pm), completed calibration and release test.The unit operated to mfr spec and was returned to clinical use.If add'l info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be failed accordingly.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER RYPE)
• 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: 4647439
• MDR Text Key: 15129417
• Report Number: 1828100-2015-00159
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/03/2015

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2002
• 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