MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1

Model Number 816571

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00381.Per the subsidiary site: they told me this roller is new, the roller never was used, but they bought three years ago.Calibration of the occlusion was performed with the method of falling water column with silastic tubing ½ inch obtaining a decrease of one inch in one minute, which is considered the ideal level of occlusivity and water recirculation is started by a period of ten minutes; after this time, the occlusivity is evaluated again showing that the water column does not drop.Subsequently, calibration of the occlusion is performed with the method of the falling water column with the manufacturer polyvinyl chloride (pvc) tubing ½ inch obtaining a decrease of one inch in one minute which is considered the ideal level of occlusivity and water recirculation is started for a period of ten minutes; after this time, the occlusivity is evaluated again showing that the water column does not drop.It checks the distance roller to roller and it is determined that the distance between them is at 0.0004 inches, therefore, distance was within the limits of tolerance set as the permitted range +/- 0.0015 in; but even with this level of calibration, the roller pump was presenting this phenomenon.At the end, we could watch that the distance roller to roller, which was 0.0004 inches, showed no change in measurements before and after testing recirculation.Repairs will be made in (b)(6), if the spare parts are needed after the replacement, the subsidiary site will send to the manufacturer.

Event Description

It was reported that during routine testing of the device at the service center, the roller pump was occluded and lost calibration.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, the reported issue was not duplicated.The product surveillance technician (pst) observed the roller pump to function properly with no loss of calibration or change in occlusion throughout evaluation.The pst connected roller pump to system-1 (aps1) power supply and powered on pump.He opened the perfusion screen and assigned the pump as arterial.The pst installed tubing, adjusted for optimal occlusion using water drop method and started the pump in forward direction.He operated the roller pump overnight and rechecked occlusion using water drop method.The pst observed no change in occlusion.The product will be 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.

Event Description

Additional information: per the follow-up clinical review on 15-aug-2016: manufacturer clinical services (cs) reviewed the reported issue and he has enough information to assess the user's observations.They were using a large system-1 (aps1) roller pump and silicone (silastic) tubing was being used in the raceway.They set the occlusion of the roller pump prior to cardiopulmonary bypass (cpb) by adjusting the occlusion to achieve a fluid drop of one inch per one minute of time.This method of setting occlusion is the method that is described in the aps1 operator manual instructions for use (ifu).After ten minutes of circulation time of the prime solution (prior to cpb), the fluid drop was checked (confirmed) and it was less than the one inch drop previously observed.The pump was checked for correct roller to roller distance and the pump did meet specification.The pump was returned to the manufacturer for testing and assessment, and it met all specifications.But, when the occlusion was set in the test lab (using one inch drop per minute) and then re-checked 15 minutes later, the same behavior was observed in that less than one inch drop per minute occured.Again, there were no functional issues found with the pump assembly.(b)(4).This paper studied the influence of a roller pump on the integrity and nature of silastic tubing.In this study, they observed the same findings in that after the pump had been operated for a period of time, the occlusion had been re-checked (by fluid drop method) and less than one inch drop per minute was discovered.In fact, in each sampling period in the 70 minute test, the fluid drop was less for each subsequent time period.The pumps were checked and no functional issues were found.During this investigational study (in the paper), they found the silastic tubing compression force had relaxed over time.This means the spring effect of the tube wall decreases with time and the available area for the prime solution in the "pump header" decreases with increasing relaxation.Over time, the fluid drop will decrease, even though the roller position or roller to roller dimensions do not change.Full functionality of the pump was found in the aa service depot and the pump meets all specifications.The observations at the hospital are confirmed and the decrease in fluid drop appears to be related to a change in tubing compression and not due to a functional issue of the pump.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5688779
• MDR Text Key: 46209538
• Report Number: 1828100-2016-00382
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• 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