MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- LIBERTY CYCLER UL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: the file was assessed to determine whether a clinical investigation is warranted.On 23/jan/2020, fresenius became aware this female patient experienced frequent hospitalizations (specifics/dates not provided) and several admissions to a nursing home (specifics/dates not provided) where peritoneal dialysis (pd) services were not offered.Additionally, the patient experienced difficulty removing and keeping fluid off, however no specifics were provided.Multiple attempts were made to obtain additional information (e.G.Discharge summaries, treatment records, progress notes); however, no further data has been provided.Presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse events occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation or objective evidence a fresenius product(s) or device(s) malfunction caused or contributed to the patient¿s hospitalizations or nursing home admissions.Therefore, the completion of a clinical investigation is not warranted at this time.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient reported via a survey that they experienced frequent hospitalizations and several admissions to a nursing home where pd treatment was not supported.It was reported that the patient had difficulties draining fluid and keeping it off.Specific details regarding hospital and nursing home admissions were not provided.It was not alleged that these events were as a result of an issue with a fresenius device, drug, or product.Multiple attempts were made to acquire additional information, however, to date a response has not been received.Since specific dates of admissions were not provided, the event date will be reported as (b)(6) 2019.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Manufacturer Narrative

Corrected information: d4- lot and serial # (auto-populated fields were not deleted) , h6 patient code c54027 (incorrect patient code used).

• Brand Name: LIBERTY CYCLER UL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9673174
• MDR Text Key: 177925884
• Report Number: 2937457-2020-00247
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 02/17/2020
• Supplement Dates FDA Received: 02/12/2020; 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization