MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

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

Patient Problem Sepsis (2067)

Event Type  Death  

Event Description

On (b)(6) 2022, a registered nurse (rn) reported that this patient on peritoneal dialysis (pd) expired was found deceased in the morning of (b)(6) 2022 while attached to the fresenius cycler.The nurse stated the cause of the patient's death was unknown in the initial report.However, there were no reported allegations the death was related to any issues with fresenius products.An additional follow-up call was made to the patient's pd nurse who confirmed the reported event.The nurse was not able to provide the phase of pd treatment when the patient expired.It was stated the patient was found deceased by the patient contact and 911 was called.Per the nurse, when emergency medical services (ems) arrived in the patient's home, cardiopulmonary resuscitation (cpr) was not performed.The patient was pronounced dead without being taken to the hospital.The nurse indicated this was a new patient on pd therapy since (b)(6) 2022.It was reported the patient was previously on hemodialysis modality but had developed a blood stream infection (bsi) from the hemodialysis catheter (not a fresenius product).The bsi led to transition to pd therapy and per the nurse the patient was on concomitant antibiotic therapy for the entire month of (b)(6).Additionally, the patient had a past medical history of diabetes mellitus (dm) type 2, below the knee amputation (bka), hypertension, coronary artery disease (cad), peripheral vascular disease (pvd), cardiac murmur, and an unspecified coagulation defect.The nurse stated it is believed the death was associated with patient's pre-existing comorbid conditions.The nurse stated the cycler is pending return to manufacturer and that pd treatment sheets were not available.It was confirmed the patient was completing pd treatments on the fresenius cycler, prior to death, without any adverse effects.Moreover, the nurse indicated that there is no suspicion of any cycler malfunctions or any issues with pd treatment related to the patient's death.It was stated the esrd death form is not available.However, the nurse reported that per the coroner's office, autopsy has been declined and the patient expired from natural causes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488294
• MDR Text Key: 320682212
• Report Number: MW5120992
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1