MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

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

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.

Manufacturer Narrative

Corrected information: 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.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 8839648
• MDR Text Key: 152617044
• Report Number: 8030665-2019-01173
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• 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,Followup
• Report Date: 09/03/2019

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: 050-87212
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 07/29/2019; 08/14/2019
• Supplement Dates FDA Received: 07/29/2019; 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 119