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

Model Number 148849

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during routine testing of the device at the service ctr, the arterial connector on the safety power module from inventory will not accept mating arterial cable connector.The module connector would only allow the cable connector to go in about half way.This is considered an "out of box" failure.There was no pt involvement.

Manufacturer Narrative

The reported complaint was confirmed by service repair technician (srt) observation.During laboratory analysis, the complaint effects were not able to be duplicated.The arterial monitor connector on the safety module accepted the lab-use arterial monitor cable.12 trials were conducted with no failures to connect witnessed.Full insertion and cable locking was achieved during all trials.Cardioplegia connector was also exercised, with no failures observed.No additional action will be taken at this time.

• 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: 4762820
• MDR Text Key: 5778044
• Report Number: 1828100-2015-00412
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• 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
• Report Date: 08/11/2015

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: 148849
• Device Catalogue Number: 148849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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