MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BULK NON STER XCOAT DELPH PUMP; CENTRIFUGAL PUMP

Model Number 3ZZ164275X

Device Problems Decoupling (1145); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, an apparent decoupling of the delphin pump head was witnessed, and a blood flow was not increasing as the rpms increased.According to the pump record, the aortic cross-clamp was placed on the aorta at 1032 and at 1035 there was an increase in rpms from 2886 at 1034 to 3096 at 1035; the clinician stated that she increased the rpms to 3500 and saw a decrease in blood flow from 2.5 to 1.8 lpm with a line pressure of 112 mmhg.The pump flow rate and rpms were stable according to the recorded information on the pump record and the post-oxygenator arterial line pressures were normal.The oxygenator inlet pressure was not monitored.According to the pump record the arterial blood flow was never below 2.9 lpm.The clinician stated, "came back up on flow looked good for a while and situation occurred another four times ¿ but it was very intermittent and very subtle, she would go up and down on rpms and then it would be okay for a while." according to the arterial pump log analysis, there were some fluctuations in rpms.There is no knowledge or information as to what may have occurred from interactions that could have affected pump flow at the patient end of the cpb circuit or clinician interactions at the sterile field.The arterial pump was stopped for approximately one minute at 1042 to check coupling of the centrifugal pump disposable to the drive motor which was not a problem.*no consequence or impact to patient, *product was not changed out, *procedure completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 10, 2018.(b)(4).A visual inspection was performed upon receipt and no anomalies were noted.The sample was connected to a pump driver and circulated at 500-2400 rpms.The flow rate of the fluid increased steadily as the rpm of the pump driver was increased (1l/min - 11l/min).No decoupling was observed during the evaluation of the complaint sample.A retention unit was evaluated the same way, and found to function as expected with no decrease in flow rate when the rpms of the pump driver was increased.Evaluation of the returned sample was found to function as intended, and with the forward flow easily achieved.The reported event was not able to recreated; therefore, the complaint was not confirmed and a definitive root cause was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: BULK NON STER XCOAT DELPH PUMP
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7772594
• MDR Text Key: 116873736
• Report Number: 1124841-2018-00179
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: WD07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 66