MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K

Model Number 16406

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the perfusion system was not switching over to battery.There was no pt involvement.

Manufacturer Narrative

The subsidiary's distributor engineer was conducting the pm on this perfusion system and he noticed that the machine was not switching onto battery.The monitors and two pumps with the battery cable were turned off when alternating current (a/c) power was off.The batteries were replaced three months ago and the voltages on them are 13 volts, indicating fully charged batteries.When on a/c, the light emitting diode (led) below shows constant green.Technical support asked the customer to check the following: check the voltage on p7 connector, not each battery and should get around 25 volts direct current (vdc).If nothing, you have a blown fuse.Check continuity across f1/f2.Both fuses should have continuity.If either one is blown, the system will not switch to battery.Per email from the subsidiary site, the system was completely charging and discharging, so it should be fine regarding the battery issue.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K
• 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: 4366164
• MDR Text Key: 5288411
• Report Number: 1828100-2014-01124
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16406
• Device Catalogue Number: 16406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: No
• 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