MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95005
Medical Device Problem Codes	Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Peritonitis (2252); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  plant investigation: a temporal relationship exists between ccpd therapy utilizing the stay safe extension set and the serious adverse events of peritonitis, characterized by mild abdominal pain, cramping, cloudy peritoneal effluent fluid, and hypertension which required hospitalization and antibiotic therapy.The pdrn stated the patient¿s hypertensive episode was due to the patient¿s stress level caused by the serious adverse events.Additionally, the pdrn attributed the cause of the peritonitis to the breach in sterility due to the cracked stay safe extension set.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Furthermore, in up to 20% of peritonitis cases no offending organism is identified.Based on the information available, the stay safe extension set cannot be disassociated from the serious adverse events.Given the temporal relationship, the verified (patient/pdrn) crack in the stay safe extension set, and no product available for manufacturer evaluation, the stay safe extension set cannot be excluded from having a causal or contributory role in the serious adverse events experienced by the patient.
Event or Problem Description
On 3/jun/2024 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a stay safe catheter extension set for renal replacement therapy (rrt) contracted peritonitis after discovering a cracked stay safe catheter extension.No additional information was provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient was undergoing ccpd on 26/may/2024, when he noticed the bed was wet.It was discovered the pd catheters¿ (not a fresenius product) stay safe extension set had cracked and was leaking dialysate (replaced 27/may/2024).The cause of the cracked extension set remains unknown.The patient called the on-call pdrn who instructed the patient to wrap the extension set in sterile gauze and report to the clinic on monday 27/may/2024.The patient presented to the outpatient home dialysis clinic with cloudy peritoneal effluent fluid and a peritoneal effluent fluid culture and cell count were obtained (wbc cell count = 2278 u/l, polymorphs = 79%) and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 2000 mg daily x 14 days; however, on 30/may/2024, the patient contacted the pdrn reporting mild abdominal pain, cramping, and hypertension (blood pressure = 190/100).The patient was instructed to go to the emergency room and was admitted for peritonitis and hypertension.The patient continued to receive cefepime while hospitalized, however it was transitioned to intravenous (iv) administration instead of ip.The patient¿s hypertension was believed to be stress related due to the peritonitis and resolved without medicinal/medical intervention.On 31/may/2024, the patient¿s peritoneal effluent fluid cultures were negative for growth, however the patient will continue the antibiotic course until completed.The patient is recovering from the events and was discharged in stable condition on 2/jun/2024.The cause of the peritonitis was attributed to the breach in sterility due to the cracked stay safe extension set.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler following discharge without reported issue.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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 or Problem Description
On 3/jun/2024 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a stay safe catheter extension set for renal replacement therapy (rrt) contracted peritonitis after discovering a cracked stay safe catheter extension.No additional information was provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient was undergoing ccpd on (b)(6) 2024, when he noticed the bed was wet.It was discovered the pd catheters¿ (not a fresenius product) stay safe extension set had cracked and was leaking dialysate (replaced (b)(6) 2024).The cause of the cracked extension set remains unknown.The patient called the on-call pdrn who instructed the patient to wrap the extension set in sterile gauze and report to the clinic on monday (b)(6) 2024.The patient presented to the outpatient home dialysis clinic with cloudy peritoneal effluent fluid and a peritoneal effluent fluid culture and cell count were obtained (wbc cell count = 2278 u/l, polymorphs = 79%) and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 2000 mg daily x 14 days; however, on (b)(6) 2024, the patient contacted the pdrn reporting mild abdominal pain, cramping, and hypertension (blood pressure = 190/100).The patient was instructed to go to the emergency room and was admitted for peritonitis and hypertension.The patient continued to receive cefepime while hospitalized, however it was transitioned to intravenous (iv) administration instead of ip.The patient¿s hypertension was believed to be stress related due to the peritonitis and resolved without medicinal/medical intervention.On (b)(6) 2024, the patient¿s peritoneal effluent fluid cultures were negative for growth, however the patient will continue the antibiotic course until completed.The patient is recovering from the events and was discharged in stable condition on (b)(6) 2024.The cause of the peritonitis was attributed to the breach in sterility due to the cracked stay safe extension set.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler following discharge without reported issue.
Additional Manufacturer Narrative
Correction provided in b1, d4, d10, h4 and h6.
Event or Problem Description
On (b)(6) 2024 during follow-up, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a stay safe catheter extension set for renal replacement therapy (rrt) contracted peritonitis after discovering a cracked stay safe catheter extension.No additional information was provided during intake.Follow-up with the patient¿s primary pd registered nurse (pdrn) revealed the patient was undergoing ccpd on (b)(6) 2024, when he noticed the bed was wet.It was discovered the pd catheters¿ (not a fresenius product) stay safe extension set had cracked and was leaking dialysate (replaced (b)(6) 2024).The cause of the cracked extension set remains unknown.The patient called the on-call pdrn who instructed the patient to wrap the extension set in sterile gauze and report to the clinic on monday (b)(6) 2024.The patient presented to the outpatient home dialysis clinic with cloudy peritoneal effluent fluid and a peritoneal effluent fluid culture and cell count were obtained (wbc cell count = 2278 u/l, polymorphs = 79%) and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 2000 mg daily x 14 days; however, on 30/may/2024, the patient contacted the pdrn reporting mild abdominal pain, cramping, and hypertension (blood pressure = 190/100).The patient was instructed to go to the emergency room and was admitted for peritonitis and hypertension.The patient continued to receive cefepime while hospitalized, however it was transitioned to intravenous (iv) administration instead of ip.The patient¿s hypertension was believed to be stress related due to the peritonitis and resolved without medicinal/medical intervention.On (b)(6) 2024, the patient¿s peritoneal effluent fluid cultures were negative for growth, however the patient will continue the antibiotic course until completed.The patient is recovering from the events and was discharged in stable condition on (b)(6) 2024.The cause of the peritonitis was attributed to the breach in sterility due to the cracked stay safe extension set.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler following discharge without reported issue.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19513610
• Report Number: 0008030665-2024-00518
• Device Sequence Number: 3982180
• Product Code: KDJ
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95005
• Device Lot Number: 24AR08121
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 10/14/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/08/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 66 KG