MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 16404

Device Problems False Alarm (1013); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the perfusionist heard air bubble detector alarming without any air in a circuit.There was a bad connection on back of safety monitor.The air detector was changed out.There was a two minute delay in starting the procedure.The surgery was completed successfully, no adverse event was reported.Per clinical review: during priming, prior to cpb, the air bubble detector was enabled from the safety monitor and an alarm occurred.According to the certified clinical perfusionist (ccp), no air was visible but the air detector continued to alarm.The ccp grabbed a spare cable that connects the air sensor to the back of the safety monitor and he changed out this cable.The cable swap allowed air detection to be reset and the system was able to be used for the procedure.During the cable swap, the ccp mentioned that the air detection module seemed to be a little loose in the back of the safety monitor.The air detector was used for the procedure and the case was completed successfully.The troubleshooting did delay the start of the procedure by about 2 minutes.There was no associated blood loss and no harm was observed.

Manufacturer Narrative

(b)(4).The complaint was duplicated during laboratory analysis.Per product surveillance technician (pst), the device under test (dut) safety monitor's air bubble detector (abd) could be turned on and would operate properly but when the cable / connection on the back was slightly moved, false air detection alarms occurred (light-emitting diode and audible alarms).After the abd card cover was removed for inspection, several fatigued and fractured solder connections at the abd connector pins were evident.This was the cause of the intermittent behavior.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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 8000 PERFUSION SYSTEM
• Type of Device: DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6549463
• MDR Text Key: 74659539
• Report Number: 1828100-2017-00223
• Device Sequence Number: 1
• Product Code: KRL
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16404
• Device Catalogue Number: 16404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2004
• 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