MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL PUMP ADAPTER

Model Number	824043
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the clinician was unable to provide forward arterial flow.Per user facility they were doing manual compressions of the heart to try to get blood pressure.They removed our adapter and placed the adapter in a hand crank and provided forward arterial flow to the patient.No known impact or consequence to patient, product was not changed out, procedure was completed successfully.
Additional 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 18, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).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, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.Visual inspection of the returned sample showed no anomalies with the device.The sample was built into a saline circuit with a sorin drive motor and a sarns centrifugal pump.The flow was monitored as the rpms were increased.The returned sample was found to pass rotational energy from the sorin drive motor to the sarns pump and flow increased as the pump rpms were increased.The reported issue was not able to be replicated; therefore, a root cause was not able to be determined.It is possible that the pump adapter or pump was set up incorrectly, causing the devices to not flow appropriately.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SARNS CENTRIFUGAL PUMP ADAPTER
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8708737
• Report Number: 1124841-2019-00168
• Device Sequence Number: 1822153
• Product Code: KFM
• UDI-Device Identifier: 00699753450417
• UDI-Public: (01)00699753450417
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 824043
• Device Catalogue Number: N/A
• Device Lot Number: WL24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention