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

Catalog Number	RTLR180237
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Constipation (3274)
Date of Event	11/01/2019
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: the file was assessed to determine whether a clinical investigation is warranted.On 4/nov/2019, fresenius became aware this female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy was hospitalized (dates not provided) for drain complications, abdominal pain and constipation (> 5 days).Subsequent attempts to obtain additional information have thus far proven unsuccessful.Gastrointestinal complications such as abdominal pain and constipation are common in the esrd population.Additionally, constipation is known to cause impaired flow of pd catheters.Based on the information available, the liberty pdx cycler is disassociated from the event, as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the adverse event(s) or hospitalization.Furthermore, to this reviewer¿s knowledge, the patient continues to utilize the same liberty pdx cycler without any reported issues or allegations of machine malfunction or deficiency.Therefore, the completion of a clinical investigation is not warranted at this time.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient was hospitalized for abdominal pain and constipation (unspecified dates of admission and discharge).The patient initially reported the hospitalization after calling to seek assistance with the cycler draining slowly and receiving a complication encountered alarm during drain 4 of 4.The patient had mentioned not having these issues while using the hospital¿s cycler during a previous hospitalization.Upon follow up with the pd registered nurse (pdrn) it was clarified that the patient was admitted on an unknown date due to more than five days of abdominal pain and constipation.Additional information has been requested, however, to date a response has not been received.There was no allegation that the patient¿s symptoms and subsequent hospitalization were related to the use of a fresenius device, drug, or product.As the event date is unknown it will be captured as (b)(6) 2019.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: LIBERTY PDX CYCLER ASSY (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: 9334085
• Report Number: 2937457-2019-03397
• Device Sequence Number: 1951251
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention