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

Model Number 3ZZ164275X

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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 prior to cardiopulmonary bypass during prime, the pumphead kept on getting bubbles from the central section of the impeller.No patient involvement.Product was changed out.Procedure was 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 june 5, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).D10 (device availability - added date returned to manufacturer).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected with no anomalies observed.The sample was built into a saline circuit and circulated at various speeds to observe the reported event.Bubbles were not observed under normal use of the pump.The returned sample was then leak tested by pressurizing to approximately 20psi and submerged in water and observed for bubbles.No bubbles were observed.A retention sample was obtained and also built into a saline circuit and circulated at various speeds to observe the reported event.Bubbles were not observed under normal use of the pump.The retention sample was then leak tested by pressurizing to approximately 20psi and submerged in water and observed for bubbles.No bubbles were observed.Upon evaluation of the returned sample, the pump was found to not form bubbles within the pump.As the reported event was not able to be replicated, a definitive root cause was not able to be determined.It's possible that the technique in the use of the pump was the cause for observing bubbles within the pump.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: 8670440
• MDR Text Key: 147054078
• Report Number: 1124841-2019-00161
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: WN20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1