MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER

Model Number 16402

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pump stopped.There was approximately a five minute delay.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the complaint.The pump was operated at various speeds, occlusion points and in different directions operating as intended throughout the evaluation.The unit operated to the manufacturer's specifications.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

As per field service representative (fsr), the reported complaint could not be duplicated.During laboratory analysis, the product surveillance technician (pst) observed the device to operate as intended throughout testing.

Event Description

Per clinical review: on (b)(6) 2017, the perfusionist (ccp) set up and primed the pump and disposable components without issue.The ccp stated that the cardioplegia (cpg) pump and circuitry associated with the myocardial protection passed its pre-cardiopulmonary bypass (cpb) safety and function tests.Shortly after initiation of cpb, the cpg pump "locked in failure mode", and was unable to turn on to allow forward flow to the myocardium.He restarted (power on/off) the cpg pump three times, and each time it would lock in a failure and not enable forward flow of the cpg solution.Ccp troubleshooting included checking the cpg pressures, pump power, wired connections, jammed buttons, pump cover placement, and he opened the cpg vent/purge line to release any pressure that could have miscalculated a different pressure.He also minimally released the set occlusion to be certain that the pump was not over occluded.During the period of pump failure, the surgeon was in the process of applying the cross-clamp, but the ccp informed the surgeon of the problem that they were unable to flow forward with the cpg solution, therefore the surgeon did not apply the cross-clamp.The fourth attempt to mitigate the problem included a complete shut down of the heart lung machine (hlm), and recycling of power.This did not resolve the cpg pump failure.The hlm was only off for a few seconds, and forward cpb was resumed in a few seconds.The ccp then tried to restart the cpg pump for a fifth time, and it was able to run appropriately.According to the ccp, no active alarms occurred.The patient received the accurate amount of cpg doses, and the pump worked without failure the rest of the procedure.The ccp stated that there was about a four to five minute delay in continuation of the surgical procedure while he was troubleshooting and resolving the problem with the roller pump.The was no blood loss or harm associated with the event.

• Brand Name: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7144070
• MDR Text Key: 95941313
• Report Number: 1828100-2017-00598
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• 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: 05/09/2018

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
• Other Device ID Number: GTIN: (01)00886799000182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/04/2018; 04/19/2018
• Supplement Dates FDA Received: 01/29/2018; 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2010
• 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