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 Problems Vomiting (2144); Peritonitis (2252); Malaise (2359)

Event Date 10/14/2019

Event Type  Injury  

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.  clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty select cycler and cycler set and the patient event of peritonitis.However, there is no documentation in the complaint file to show a causal relationship.Additionally, there is no allegation of a device malfunction or deficiency or a cycler set leak or defect.The pdrn reported the cause of the peritonitis as a breach in aseptic technique as evidenced by the culture result of streptococcus.Streptococci organisms are part of the normal flora in the mouth and gastrointestinal tract.Based on the available information, the liberty select cycler and cycler set can be excluded as the cause of the patient¿s peritonitis event.

Event Description

It was reported that a peritoneal dialysis (pd) patient felt sick and was vomiting due to peritonitis.The patient came into the clinic on (b)(6) 2019 for a routine clinic visit and complained of vomiting and abdominal "bruising." cultures confirmed abdominal infection, and the patient has been on antibiotics since.The pd effluent cultures were positive for gram-positive cocci, alpha-hemolytic streptococcus (species unknown) with a white cell count of 9,765 (unknown units).The patient was prescribed/treated with intraperitoneal (ip) ceftazidime, 2g daily for 6-hour dwell (duration unknown) and ip vancomycin 1,500mg daily with a 6-hour dwell (unknown duration).The nurse stated that the patient is doing better and recovering.The nurse attributed the infection to the patient not washing her hands or using a mask prior to treatment on (b)(6) 2019.The patient¿s last white cell count was 12 (unknown units).A final culture will be obtained when the patient completes antibiotic therapy (unknown date).The nurse stated that this lack of adherence to aseptic technique while the patient performed dialysis was the likely cause of peritonitis.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9272788
• MDR Text Key: 165058596
• Report Number: 8030665-2019-01696
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2019

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68