MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 050-50758

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/08/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal and possible casual relationship between the use of the stay safe mts set and the patient event of peritonitis.However, the set is not available to return for evaluation by the manufacturer and there are no photographs sent to show the leak.The patient had reported multiple leaks with two different lots.It is unknown which lot is related to the peritonitis event.The culture resulted positive for acinetobacter radioresistens which can be found in moist skin areas which could also suggest a possibility of a breach in aseptic technique occurred.Based on the available information, the exact cause of the patient¿s peritonitis cannot be determined.The stay safe mts set cannot be excluded as causing or contributing to the peritonitis event.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.Upon follow up, the pd registered nurse (pdrn) reported the patient was seen in the pd clinic with complaints of abdominal pain.A pd effluent culture was obtained, and the patient was diagnosed with peritonitis.The patient was initiated on intraperitoneal (ip) antibiotics with vancomycin 2g and ceftazidime 2g.The patient continued with ip ceftazidime daily and received a second dose of vancomycin on (b)(6) 2021.The pd effluent culture resulted positive for acinetobacter radioresistens.The vancomycin was discontinued, and the patient has continued to take ceftazidime 2g daily.The cause of the patient¿s peritonitis event was attributed to the reported leak of the stay safe mts set.The patient was not hospitalized for this event and continues to complete treatment utilizing the liberty select cycler.

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 stay safe mts 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.

Event Description

It was reported that a peritoneal dialysis (pd) patient was diagnosed with peritonitis.Upon follow up, the pd registered nurse (pdrn) reported the patient was seen in the pd clinic with complaints of abdominal pain.A pd effluent culture was obtained, and the patient was diagnosed with peritonitis.The patient was initiated on intraperitoneal (ip) antibiotics with vancomycin 2g and ceftazidime 2g.The patient continued with ip ceftazidime daily and received a second dose of vancomycin on (b)(6) 2021.The pd effluent culture resulted positive for acinetobacter radioresistens.The vancomycin was discontinued, and the patient has continued to take ceftazidime 2g daily.The cause of the patient¿s peritonitis event was attributed to the reported leak of the stay safe mts set.The patient was not hospitalized for this event and continues to complete treatment utilizing the liberty select cycler.

• Brand Name: STAY SAFE MTS SET
• 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
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13099959
• MDR Text Key: 285174474
• Report Number: 8030665-2021-01920
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100699
• UDI-Public: 00840861100699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 050-50758
• Device Catalogue Number: 050-50758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/12/2022
• 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
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male