MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	180111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: attempts to obtain additional information were unsuccessful.The reason for the patient¿s hospitalization is unknown; however, there is no allegation of a device malfunction or deficiency reported for the event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Therefore, the completion of a clinical investigation is not warranted at this time.
Event or Problem Description
It was reported a hospital nurse contacted fresenius technical support for air detected in cassette warnings in drain 0 for a hospitalized patient utilizing the liberty cycler.During the call the cycler moved forward to fill 1 with no further alarms.Attempts to obtain additional information were unsuccessful.The reason for the patient¿s hospitalization is unknown; however, there is no allegation of a device malfunction or deficiency reported for the event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.
Additional Manufacturer Narrative
Correction: b2 hospitalization - initial or prolonged changed from "no" to "yes", b3 (unknown admit date) upon receipt of additional information, it was determined that the event reported in mfr 2937457-2021-01828 had no patient identified and the cycler belonged to the acute center, and is not a reportable event related to fmcrtg products.There was no serious injury, adverse event, or reportable malfunction.There will be no further updates on 2937457-2021-01828.
Event or Problem Description
It was reported a hospital nurse contacted fresenius technical support for air detected in cassette warnings in drain 0 for a hospitalized patient utilizing the liberty cycler.During the call the cycler moved forward to fill 1 with no further alarms.Attempts to obtain additional information were unsuccessful.The reason for the patient¿s hospitalization is unknown; however, there is no allegation of a device malfunction or deficiency reported for the event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12408517
• Report Number: 2937457-2021-01828
• Device Sequence Number: 14735314
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: Hospitalization; Other