MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

Model Number 816571

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), the roller pump passed all testing meeting specifications.The roller to roller measurement was unchanged from previous testing.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb), the roller pump was being used in the cardioplegia (cpg) position and there was a pump jam.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the team uses an 8:1 tubing pack for the delivery of cardioplegia (cpg).The team has had a previous complaint place for pump jam situation occurring on cardiopulmonary bypass (cpb)((b)(4)).During the initial discussion regarding the pump jam concern, the perfusionist noted that the team was used to the loading of the set, priming, and usage of roller pumps on a different heart-lung machine (hlm).The techniques they had employed to load, prime, and use the roller pump were exactly the same to the previous pumps.He had stated that the team had put in some additional protocols to mitigate the possibility of this problem occurring in the future, which is allowing the tubing and roller pump to warm up prior to initiation of placement of the cross-clamp and being aware of the usage of the tubing clamp guides when loading the 8:1 set in the roller raceway.On (b)(6) 2018, the team had another pump jam occurrence, during the delivery of the cpg.The tubing clamp holders were verified and the length of the tubing in the raceway, along with the occlusion being set were done prior to the initiation of the cpg dosages.Once the cross clamp was on the pump for approximately two minutes, and then were able to deliver another liter of cpg to the surgeons satisfaction.When the cpg pump was not running the team spent five to seven minutes checking the occlusion again and recirculating the pump, and they felt the issue was fixed.At twenty minutes of ischemic time, they were asked to give another dosage of cpg, and with only 100 milliliters (ml) of the dose delivered to the heart, the pump jammed a second time.They again adjusted the occlusion and tubing clamp holders, and were unable to resolve the issue.They were receiving pump jam and belt slip error messages during this second occurrence.The team opted to exchange the roller pump.This took approximately 10 minutes of time.They placed the original disposable in another roller pump that they placed on the base, and were able to deliver subsequent cpg dosages without issue.There was no delay in the continuation of the surgical procedure.The incident did not cause either blood loss or harm to the patient.

Manufacturer Narrative

The manufacturer's clinical specialist visited the user facility to try to get additional information about the perfusion team's troubles with the pump jam.The process of setting up the 8:1 tubing set in their roller pump was discussed, and the different techniques some of the team uses to load the tubing.They discussed the process of allowing the pump to run continuously while the arterial pump is running, after the conclusion of the priming process, and prior to the initiation of cpb.The team has seen both bunching up of the tubing on the outlet side of the roller pump, and the 8:1 tubing rolling in on itself on the outlet side of the roller pump.On the outlet side, post the tubing guide clamps, the team has tie-banded the tubing to mitigate the issue,.Additionally, some of the staff has tie-banded the inlet side of the tubing proximal to the tubing guide clamps.The team has set occlusion to the smaller tubing on their 8:1 tubing set.It was discussed and decided with the perfusion team to trial a 4-inch roller pump in the cpg location to see if this helps mediate the pump jam issue.By using a 4-inch roller pump, the location of the flexible ys on their tubing set would be in a different location, further from the raceway.Per data log analysis, on (b)(6) 2018 the logs reported the following: (b)(6).The log confirms the complaint, three pump jams occurred.

Manufacturer Narrative

Additional parts for evaluation were received on 01-feb-2019.During laboratory analysis, the product surveillance technician (pst) observed that pump and customer pump and tubing set to function as intended.No pump jam observed during testing per known perfusionist techniques.

Manufacturer Narrative

The reported complaint was confirmed in the logs.The service repair technician (srt) found the device to pass all required testing.The unit operated to the manufacturer's specifications.Pump was set to proper occlusion during all lab and service checks.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8237589
• MDR Text Key: 133063277
• Report Number: 1828100-2019-00022
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180224
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2019

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/11/2019; 02/01/2019; 04/11/2019
• Supplement Dates FDA Received: 02/04/2019; 02/26/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention