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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Myocardial Infarction (1969); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/24/2020

Event Type  Injury  

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported that they were immobile after undergoing "heart surgery." follow-up with the patient's pd registered nurse (porn) revealed the patient was hospitalized on (b)(6) 2020, due to a non-st elevation myocardial infarction (nstemi).The patient reportedly completed ccpd therapy earlier that morning without incident.Later that afternoon, the patient suffered an nstemi and was transported to the hospital via emergency medical services (ems).Per the porn, the patient required an emergent coronary artery bypass graft (cabg) x3 which was successfully completed on (b)(6) 2020.On (b)(6) 2020 the patient was transferred to a rehabilitation unit for continued monitoring and physical therapy.While in the hospital, the patient continued to undergo ccpd therapy without issue.The patient was scheduled to transfer to a skilled nursing facility (snf) on (b)(6) 2020; however, the snf could not offer pd services.Therefore, the nephrologist ordered the patient receive a hemodialysis (hd) catheter (not a fresenius product) to transition to hd therapy while residing in the snf.The hd catheter was successfully placed on (b)(6) 2020, and the patient underwent an initial hd treatment on (b)(6) 2020 without issue.While residing at the snf, the patient received outpatient hd therapy without issue.The patient's pd catheter (not a fresenius product) was left intact and was monitored by the clinic staff.On (b)(6) 2020, the patient was discharged home, where she continued to undergo outpatient hd therapy until (b)(6) /2020.On (b)(6) 2020, the patient returned to ccpd therapy utilizing the same liberty select cycler as before the events.The patient has recovered from the events and has resumed utilizing the same liberty select cycler as before the events.The porn reported the serious adverse events were unrelated to the patient's utilization of any fresenius product(s) and/or device(s).(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: 17526651
• MDR Text Key: 321153218
• Report Number: MW5133589
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1