BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DIALYSIS

    MDR report key: 22479908 · Received July 11, 2025

    Report

    Report Number
    1282497-2025-00498
    Event Type
    Death
    Date Received
    July 11, 2025
    Date of Event
    March 7, 2025
    Report Date
    July 11, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ABDULLAH ALHWIESH, IBRAHIEM SAEED ABDUL-RAHMAN, MOHAMMED AHMED NASR EL-DIN, MOAZ ABDULGALIL, MOHAMMED ABDELMEGEED SAKR, KHADIJA M. A LSHEHABI, NADIA AL-AUDAH URGENT UNPLANNED PERITONEAL DIALYSIS VERSUS HEMODIALYSIS IN END-STAGE RENAL DISEASE: COSTS AND OUTCOMES THER APHER DIAL. 2025;29(3):437¿46. HTTPS://DOI.ORG/10. 1111/1744-9987.70007 D10 - CONCOMITANT PRODUCT: PERITONEAL CATHETER LOT UNKNOWN PERITONEAL CATHETER LOT UNKNOWN PERITONEAL CATHETER LOT UNKNOWN DIALYSIS UNKNOWN LOT UNKNOWN DIALYSIS UNKNOWN LOT UNKNOWN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    PLI 10: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. TWO-CUFF CURLED TENCKHOFF PD CATHETERS WERE INSERTED PERCUTANEOUSLY INTO 30 PATIENTS BY THE DIALYSIS UNIT NEPHROLOGISTS. TWO PD PATIENTS (6.7%) DIED. OVERALL MORTALITY RATES AFTER 3 MONTHS WERE 6.7% FOR PD. PLI 20: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. TWO-CUFF CURLED TENCKHOFF PD CATHETERS WERE INSERTED PERCUTANEOUSLY INTO 30 PATIENTS BY THE DIALYSIS UNIT NEPHROLOGISTS. IN THE PD GROUP, INFECTIOUS COMPLICATIONS INCLUDED EXIT-SITE INFECTIONS IN 2 PATIENTS (6.7%) AND PERITONITIS IN 2 PATIENTS (6.7%), WHICH WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS WITHOUT THE NEED FOR CATHETER REMOVAL. BACTEREMIA WAS REPORTED IN 1 PD PATIENT (3.3%). HOSPITALIZATION DAYS POST-DIALYSIS INITIATION AVERAGED 6.2 ± 3.3 FOR PD PATIENTS, WITH AN AVERAGE OF 4 RE-HOSPITALIZATIONS DURING THE OBSERVATION PERIOD. PLI 30: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. TWO-CUFF CURLED TENCKHOFF PD CATHETERS WERE INSERTED PERCUTANEOUSLY INTO 30 PATIENTS BY THE DIALYSIS UNIT NEPHROLOGISTS. MECHANICAL COMPLICATIONS IN PD PATIENTS INCLUDED CATHETER TIP MIGRATION, DIALYSATE LEAKS, AND CATHETEROBSTRUCTION. IN THE PD GROUP, 4 PATIENTS (13.3%) EXPERIENCED CATHETER LEAKAGE, AND 4 PATIENTS (13.3%) EXPERIENCED CATHETER OBSTRUCTION AS THE PRIMARY MECHANICAL COMPLICATIONS AFTER 2 WEEKS OF THERAPY, BUT THESE WERE SUCCESSFULLY MANAGED WITHOUT TREATMENT INTERRUPTION. THERE WAS NO REPORTED PATIENT OUTCOME. PLI 40: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. ALL CENTRAL VENOUS CATHETERS (CVCS) USED FOR HEMODIALYSIS WERE 11.5 FRENCH DOUBLE-LUMEN MAHURKAR CATHETERS. THREE HD PATIENTS (10.0%) DIED. PLI 50: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. ALL CENTRAL VENOUS CATHETERS (CVCS) USED FOR HEMODIALYSIS WERE 11.5 FRENCH DOUBLE-LUMEN MAHURKAR CATHETERS. FOR HEMODIALYSIS (HD) PATIENTS, CATHETER-RELATED INFECTIONS, INCLUDING CVC-RELATED BACTEREMIA OR SEPSIS, WERE DIAGNOSED WHEN BLOOD CULTURES PERFORMED IN RESPONSE TO A SIGNIFICANT INCREASE IN C-REACTIVE PROTEIN (CRP) OR PATIENT DETERIORATION YIELDED POSITIVE RESULTS, OR WHEN BLOOD CULTURES DRAWN DIRECTLY FROM THE CATHETER WERE POSITIVE ALONG WITH CLINICAL AND LABORATORY EVIDENCE OF INFECTION AND SEPSIS. INFECTIOUS COMPLICATIONS INCLUDED EXIT-SITE INFECTIONS IN 6 PATIENTS (20%) AND BACTEREMIA IN 7 PATIENTS (23.3%) (P = 0.008). CATHETER INFECTION OCCURRED IN 6 PATIENTS (20.0%) (P <(><<)> 0.01), NECESSITATING CATHETER AND SITE REPLACEMENT IN 4 PATIENTS (13.3%). PATIENTS WERE HOSPITALIZED FOR AN AVERAGE OF 13.6 ± 4.1 DAYS POST-DIALYSIS INITIATION, WITH AN AVERAGE OF 5 RE-HOSPITALIZATIONS DURING THE OBSERVATION PERIOD. PLI 60: ACCORDING TO THE LITERATURE SOURCE OF STUDY, A PROSPECTIVE COHORT QUASI-EXPERIMENTAL STUDY ENROLLED A TOTAL OF 67 PATIENTS WITH ESRD (END-STAGE RENAL DISEASE) REQUIRING DIALYSIS WHO WERE RANDOMLY ASSIGNED TO EITHER PD (PERITONEAL DIALYSIS) OR HD (HEMODIALYSIS) TREATMENT REGIMENS. FROM THE POOL OF POTENTIAL PARTICIPANTS, 34 PATIENTS UNDERGOING HEMODIALYSIS AND 33 RECEIVING PERITONEAL DIALYSIS WERE IDENTIFIED. HOWEVER, SEVEN INDIVIDUALS (FOUR FROM THE HEMODIALYSIS GROUP AND THREE FROM THE PERITONEAL DIALYSIS GROUP) WERE EXCLUDED FROM THE STUDY, WHICH IS WHY THE FINAL COHORT CONSISTED OF 60 ESRD PATIENTS. ALL 60 PATIENTS HAD STAGE 5 CKD (CHRONIC KIDNEY DISEASE), AS EVIDENCED BY A CREATININE CLEARANCE OF LESS THAN 15 ML/MIN (MILLILITERS PER MINUTE), AND REQUIRED IMMEDIATE, UNSCHEDULED DIALYSIS THERAPY. COMORBIDITIES OBSERVED AMONG ALL PATIENTS ENROLLED IN THE STUDY INCLUDED DIABETES, HYPERTENSION, CARDIOVASCULAR DISEASE, CHRONIC HEART FAILURE (NEW YORK HEART ASSOCIATION [NYHA] STAGE III¿IV), CEREBROVASCULAR DISEASE, AUTOIMMUNE DISEASE, MALIGNANCY, HYPERVOLEMIA, AND UREMIA. NOTABLY, AMONG THE PD GROUP, 5 PATIENTS HAD PRE-EXISTING CHRONIC HEART FAILURE. THE PRIMARY OBJECTIVE WAS TO COMPARE MORTALITY RATES BETWEEN THE TWO GROUPS, WHILE SECONDARY OBJECTIVES INCLUDED COMPARING COMPLICATION RATES AND OVERALL HEALTHCARE COSTS. ALL CENTRAL VENOUS CATHETERS (CVCS) USED FOR HEMODIALYSIS WERE 11.5 FRENCH DOUBLE-LUMEN MAHURKAR CATHETERS. IN THE HD GROUP, CATHETER OBSTRUCTION (PARTIAL OR TOTAL) OCCURRED AS THE INITIAL COMPLICATION IN 3 PATIENTS (10%) AND WAS RESOLVED THROUGH CATHETER MANIPULATION. CATHETER LEAKAGE WAS REPORTED IN 5 PATIENTS (16.7%). THERE WAS NO REPORTED PATIENT OUTCOME. URGENT UNPLANNED PERITONEAL DIALYSIS VERSUS HEMODIALYSIS IN END-STAGE RENAL DISEASE: COSTS AND OUTCOMES: ABDULLAH ALHWIESH, 2025, THERAPEUTIC APHERESIS AND DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073098 UNKNOWN DIALYSIS CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LLC UNKNOWN DIALYSIS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Other| D| H| R SEE H11