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 Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per customer, the switch on the battery back-up unit was in the connect position.Per field service representative (fsr), the customer swapped with another unit but it failed.As a result, they swapped out the entire heart lung machine.Issue was verified by the fsr, the unit would not power up on battery power.The fsr found the output fuse was blown.The blown fuse was removed and returned to manufacturer for evaluation.A new fuse was installed and batteries were replaced as a precaution.The unit performed to and met manufacturer's specifications.This complaint is related to (b)(4) / medwatch #1828100-2017-00093.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the battery would not connect or power up the centrifugal controller.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the returned line fuse to be open (blown).Both batteries exhibit signs of internal degradation and the pair fails load testing.Batteries both measured 12.9 volts direct current (vdc) upon receipt (typical).Conductance measurements were 129 siemens (s) on the first, and 140s for the second battery.Seventy five (75) s is the minimum requirement specified.Attached device under test (dut) batteries to lab-use delphin battery (charger) and powered on.After charging for 25 hours, the battery voltage readings were both 13.2 vdc.Conductance values remained 129 and 140s respectively (passing).A load test was performed by attaching a delphin (centrifugal) controller with centrifugal motor, and driving a disposable pump head at 2500 rpm with a short water loop attached.The batteries should run the device for a minimum one hour and 45 minutes under these conditions.The charger gauge indicated a drop to 50% after 25 minutes of testing.The test was aborted after about 55 minutes, when the gauge indicated at the top of the red (discharged) zone of the meter.At this point of the test, the pump rpm had dropped from 2500 to 2050 rpm, indicating the batteries were drained.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.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: 6352351
• MDR Text Key: 68379928
• Report Number: 1828100-2017-00094
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-06/29/12-020-C
• Patient Sequence Number: 1