MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000

Model Number 16402

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The ccp put the suspect roller pump on the other base unit (pump #7), but still got the "overspeed1" error message and the pump would not turn on.When the roller pump is started the over speed message is instantly displayed.The field service representative (fsr) replaced the pump central processing unit (cpu) printed circuit (pc) assembly still the over speed message appeared after the repair.The customer sent in the roller pump to the manufacturer for evaluation.Both the cpu and the roller pump with the new replacement part were sent back to the manufacturer for further evaluation.The suspect cpu was received on 28-sep-2015 and the suspect roller pump was received by the manufacturer on 29-sep-2015 for further evaluation.

Event Description

It was reported that during pre-cardiopulmonary bypass procedure, after handing sterile lines to the table, the perfusionist (ccp) turned off the arterial roller pump by turning the flow to zero.Then after handing up the lines, the pump had an error message "overspeed1" displayed.The ccp pushed the pump "on" buttons on the panel and got a green light, but when he turned the speed knob, the same message appeared and the pump would not run.Twice the ccp powered down that individual roller pump to reset it, but still got the same "overspeed1" error message and the pump would not turn on.The ccp then powered down the entire 8k base unit and turned it back on, but got the same error message and the pump would not turn on.We then swapped out the roller pump with another roller pump from a different 8k perfusion system.The new pump turned on without problem.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical summary on (b)(6) 2015: prior to cardiopulmonary bypass (cpb), the arterial roller pump was slowed down to zero revolutions per minute (rpm) as the pump lines were directed up on the surgical field in preparation of connection to the cannulae.After the lines were secured, the ccp looked at the arterial pump and an "overspeed1" message was displayed on the roller pump.The ccp touched the "start" button and turned the speed knob, but the pump did not rotate and again "overspeed1" was displayed on the pump.The circuit breaker switch for this individual pump was cycled on and off twice, but the "overspeed1" message remained.The ccp powered down the entire 8000 base and powered the base back on, but the same "overspeed1" message was displayed on this roller pump.This pump was removed from the base and a back-up pump was placed on the base and the arterial pump tubing was loaded in the pump race and the occlusion was checked.This pump worked per expectation and was used for the procedure, without issue.The case was completed successfully and this did not delay the start of cpb and did not delay the surgical procedure.There was no associated blood loss and no harm was observed.

Manufacturer Narrative

The reported complaint was confirmed by both the product surveillance technician (pst) and the service repair technician (srt).During the laboratory evaluation, the pst found that the mass termination of wires (mta) connector and pin to the power/driver board had overheated and blackened, resulting in the observed overspeed error.There was no apparent physical cause such as damage, misalignment, or oxidation of the connector and pin.The components were replaced and the issue was resolved, with the pump performing to specification.The product was sent to service to be brought to manufacturers 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.

Manufacturer Narrative

The overspeed 1 error was not initially observed by the service repair technician and occurred after extended testing, indicating that this failure is intermittent.These findings reflect the troubleshooting and repair failure observed by the field service representative for on-site servicing.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: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5144341
• MDR Text Key: 28468864
• Report Number: 1828100-2015-00877
• Device Sequence Number: 1
• Product Code: DWA
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2015; 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• 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
• Patient Outcome(s): Required Intervention