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 Problem Peritonitis (2252)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

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 that they were hospitalized for peritonitis.Upon follow up with the patient¿s peritoneal dialysis nurse (pdrn), it was reported that the patient was hospitalization from (b)(6) 2019.A peritoneal effluent fluid culture and a white blood cell (wbc) count were obtained (date not provided) and identified a gram-negative klebsiella pneumoniae and an elevated count of 21 (unit not provided), respectively.The patient was initially treated with intraperitoneal (ip) vancomycin and ceftazidime (dosages, frequency and durations not provided).However, the vancomycin was discontinued when the culture results were released.The patient underwent pd therapy while hospitalized and continues to undergo pd therapy post discharge and he is asymptomatic and recovering.It was reported that the source of contamination was from the patient's bowels and was unrelated to any fresenius products.

Manufacturer Narrative

Clinical investigation:a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the adverse event of peritonitis, which warranted hospitalization and antibiotic therapy.Per the pdrn, the source of the peritonitis was the patient¿s bowels.Klebsiella pneumoniae is normal flora of the human mouth and intestine (2,3).The pdrn stated the event was unrelated to any fresenius device(s) or product(s).Therefore, based on the information available, the liberty select cycler and liberty cycler set can be disassociated as there is no allegation or objective evidence indicating a liberty select cycler product deficiency or malfunction caused or contributed to the event.It is well established those individuals undergoing pd therapy are at high risk for infections of the peritoneum (1).Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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.A serial number search in the complaint database found two complaints with the issue of mwd watchdog timer error reported within 90 days of the notified date.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: 8839649
• MDR Text Key: 152623949
• Report Number: 2937457-2019-02362
• 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,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: 07/29/2019
• 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; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 119