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

Model Number LIBERTY SELECT CYCLER

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

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Peritonitis (2252)

Event Date 06/01/2018

Event Type  Injury  

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.Clinical investigation: there is a temporal relationship between the event of peritonitis with hospitalization and pd therapy on the liberty select cycler with cycler set.However, there is no documentation to show a causal relationship between the peritonitis and the liberty select cycler or cycler set.Additionally, there is no allegation against any fresenius product for this event.Based on available information, a cause for the peritonitis cannot be concluded.There is a possible temporal relationship between the patient¿s chest pain and pd therapy on the liberty select cycler, however, it is unknown if the patient was in treatment at the time of the event.The patient was subsequently diagnosed with nstemi in the setting of hypertension which was most likely the cause of the chest pain.There is no documentation in the complaint file to show a causal relationship and there is no allegation of a machine malfunction or deficiency for this adverse event.

Event Description

Documented in the discharge summary for a separate event was a report of another hospitalization for this male patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt).The report stated the patient was hospitalized in (b)(6) 2018 (date unknown) for chest pain and while hospitalized was diagnosed with peritonitis (signs/symptoms unknown).The patient was treated/prescribed antibiotics (type, route, dose, strength, frequency and duration unknown).The patient was also diagnosed with non st elevation myocardial infarction (nstemi) type 2 in the setting of hypertension.The patient left the hospital against medical advice (ama) with a prescription for hydralazine (route, dose, strength, frequency and duration unknown) and with good blood pressure control.It is unknown if the patient continued pd therapy during the hospitalization or if any fresenius product was utilized.Attempts for further information were unsuccessful as the patient¿s peritoneal dialysis registered nurse (pdrn) stated she was unaware of any hospitalization or event of peritonitis.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7751718
• MDR Text Key: 116066072
• Report Number: 2937457-2018-02237
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2018

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 Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR