MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS DELPHIN BASE ADAPTER WITH BATTERY; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE- SARNS CENTRIFUGAL SYSTEM

Model Number 9490

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per facility's biomed supervisor, the unit was moved to their back hallway with a note not to use because of the broken switch.

Event Description

It was reported that during the use of the device for a non-clinical activity, the power switch of the centrifugal battery was loose.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The field service representative (fsr) verified the broken switch.He installed a loaner battery wedge.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed that the orange ¿orange/disconnect¿ rocker switch cover was broken but still in place.The broken rocker switch was operable mechanically and electrically.After attaching the device under test (dut) to alternating current (ac) and ¿topping off¿ the battery charge for 24 hours, the panel meter indicated midrange of the green ¿charge¿ zone with the switch moved to the ¿connect¿ position.This indicated full charge.The switch¿s internal light remained functional in this position as designed.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 DELPHIN BASE ADAPTER WITH BATTERY
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE- SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6264600
• MDR Text Key: 65573945
• Report Number: 1828100-2017-00027
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9490
• Device Catalogue Number: 9490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2012
• 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