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

Catalog Number RTLR180343

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

Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252)

Event Date 04/06/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler/liberty cycler set and the adverse event(s) of abdominal pain, cloudy effluent and fever which warranted hospitalization and initiation of antibiotic treatment.Based on the information available, the cause of the patient's streptococcus mitis peritonitis is unknown.However, there is no allegation nor any objective evidence indicating the patient¿s liberty select cycler and/or liberty cycler set caused or contributed to the patient's event of peritonitis.Peritonitis is a well-known potential complication in patients utilizing pd therapy.Streptococcus mitis is a known colonizer of the human oropharynx and gastrointestinal tract.The entry pathway of this bacterium into the peritoneal cavity can include contamination during the exchange procedure, gastrointestinal bacterial translocation, and hematological dissemination with oral and dental procedures as well as catheter contamination.

Event Description

On (b)(6) 2019, this (b)(6) female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was reported to have developed peritonitis.There were no reported liberty select cycler/liberty cycler set product(s) issues or malfunctions reported during this initial call.Upon follow-up, the peritoneal dialysis registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2019 for abdominal pain, cloudy pd effluent, and fever.A sample of pd effluent was obtained for culture and cell count and the patient was prophylactically treated for suspected peritonitis with intraperitoneal (ip) vancomycin (1.9 gram), and ceftazidime (1.9 g gram) times one dose.The pdrn also reported, the patient was discharged to their home on (b)(6) 2019.The pdrn stated on (b)(6) 2019, the patient¿s pd effluent cultures yielded growth of streptococcus mitis, confirming a diagnosis of peritonitis.Cell count was not available.Per the pdrn, the patient was started on and is currently completing a 28-day course of vancomycin, 0.5 gram via ip dwell every 4 days.The pdrn also reported the cause of peritonitis is unknown.Additionally, the pdrn states the patient denied experiencing any fluid leaks liberty select cycler/liberty cycler set product issues or malfunctions related to this event; and the patient is recovering and continues pd treatment without further reported issues.

Manufacturer Narrative

Correction: removed life threatening from adverse event.Patient codes 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 SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8550308
• MDR Text Key: 143245245
• Report Number: 2937457-2019-01200
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/29/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 93