MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 02/18/2019

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 pd therapy with the liberty select cycler and liberty cycler set and the patient¿s event of peritonitis.However, there is no evidence to show a causal relationship between the liberty select cycler/liberty cycler set and the event of peritonitis.There is no report of a machine malfunction for this event.The peritoneal dialysis registered nurse (pdrn) reported the cause of the peritonitis was unknown.The pd culture results for this event of peritonitis revealed gram-negative bacilli and enterobacter cancerogenus.Gram-negative peritonitis may result from touch contamination, exit site infection, or possibly a bowel source such as constipation, colitis, or transmural migration, but the cause is often unclear, as was the case with this patient.

Event Description

It was reported that a peritoneal dialysis (pd) patient was seen at the outpatient dialysis clinic on (b)(6) 2019.The patient had cloudy pd effluent but no fever or abdominal pain.The patient was referred to the hospital and subsequently admitted with a diagnosis of peritonitis.Pd effluent cultures revealed a white blood cell count of 1680 (units of measure & reference ranges not provided), gram negative bacilli, and enterobacter cancerogenus.The patient was treated with gentamycin (dose not provided) ip x 10 days.The patient was hospitalized for three days and discharged on an unspecified date.The cause of the peritonitis was unknown per the pdrn.The patient had no reported issues with the liberty select cycler prior to this event.The event of peritonitis was not related to treatment with the liberty select cycler or any other fresenius products or equipment per the pdrn.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.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.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8535546
• MDR Text Key: 142618867
• Report Number: 8030665-2019-00618
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR