MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 050-95005

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

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

Event Date 12/28/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with cycler set and the patient event of staphylococcus capitis peritonitis.However, there is no documentation in the complaint file to show a causal relationship between the event and utilization of the liberty select cycler and cycler set.Additionally, there is no allegation of a machine malfunction or deficiency or cycler set leak reported for the peritonitis.Although the cause of the peritonitis is unknown, the culture result of staphylococcus capitis suggests a breach in aseptic technique.Staph capitis is a known organism on human skin and known to be linked with catheter-related infection.The cause of the pd catheter and extension set turning blue has not been determined.There is no literature pertaining to this scenario where the fluid remains clear without also turning blue.Based on the available information and no allegation or evidence of a malfunction, deficiency or defect the liberty select cycler and cycler set can be excluded as the cause of the patient¿s staphylococcus capitis peritonitis.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient was diagnosed with peritonitis.The initial complaint details alleged that there was an unspecified infection.Upon follow up on (b)(6) 2020, the initial reporter, the patient¿s pd clinic¿s program manager (pm), reported that the patient had presented to the local emergency room on (b)(6) 2019 for cloudy pd effluent and abdominal pain.A pd effluent culture was obtained, and the patient had a computed tomography (ct) scan without contrast.No medication was administered to the patient and they were discharged within 24 hours.On (b)(6) 2019 the patient was seen at the pd clinic.The patient was asymptomatic, and it was noted that the patient¿s pd effluent was slightly cloudy.The patient was given antibiotics vancomycin 1g and gentamycin 100mg via intraperitoneal (ip) administration and instructed to swell for 6 hours.On (b)(6) 2019 there was no growth and no organism seen on the culture after two days.On (b)(6) 2020 the patient was seen at the clinic for a follow-up appointment.Patient was asymptomatic and their pd effluent was clear.Another culture was obtained.The patient reported that his pd catheter (covidien product) and extension set (fmc product) had turned blue the previous day.The pd nurse tried to wipe the set with an alcohol rub, but no color came off the tubing.After examination by the pd nurse it was determined that the blue coloring was on the inside of the extension set and catheter.The patient¿s extension set was changed out.There were no medication changes nor consumption of unusual liquids reported.On this date the pd effluent culture results from the hospital came back positive for staphylococcus capitis.The patient was administered a dose of ip vancomycin 1500mg for 3 doses for peritonitis.On (b)(6) 2020 the pd nurse conducted a home visit and the extension set was blue again with clear pd effluent.The surgeon who implanted the catheter and the catheter manufacturer, covidien, were contacted and they indicated they were unaware of similar cases of catheters turning blue.One of the extension sets is available at the clinic and a sample return was scheduled.Once returned the sample will undergo a physical evaluation by the manufacturer.A cause was not alleged nor identified for the patient¿s peritonitis.The patient remains asymptomatic and continues to complete pd therapy on the same liberty select cycler.

Manufacturer Narrative

Plant investigation: the device was returned to the manufacturer and a physical evaluation was performed.During the disinfection of the actual sample the alleged blue color was confirmed.The cause of the blue color could not be established.A lot number for the product 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.Only lot # 19hr08110 was identified in the patient's recently shipped orders.The entire lot has 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.Based on the results of the investigation, the alleged discoloration was confirmed, however, a cause could not be confirmed.There was no indication that the sample's condition attributed to the patient's symptoms.The returned sample was scrapped after evaluation.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9646060
• MDR Text Key: 178355086
• Report Number: 8030665-2020-00141
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (y/n): N
• PMA/PMN Number: K904806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

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: 050-95005
• Device Catalogue Number: 050-95005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Device Age: MO
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 02/11/2020
• Supplement Dates FDA Received: 02/06/2020; 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR