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

Catalog Number UNKNOWN PD CATHETER

Device Problems Migration or Expulsion of Device (1395); Output Problem (3005)

Patient Problems Dyspnea (1816); Cardiac Enzyme Elevation (1838)

Event Date 08/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, fresenius became aware this 75-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) went to the emergency room (er) "over the weekend" due not feeling well.No additional information provided during intake.During follow-up, the patient's outpatient home dialysis clinic confirmed the patient went to the er on (b)(6) 2021 but left due to a prolonged wait time.The patient presented to the outpatient dialysis center the following day on (b)(6) 2021 with dyspnea, an elevated bun (value unknown) and complaints of drain complications preventing the patient from completing ccpd therapy (unknown duration).The patient was sent back to the hospital and radiological studies revealed the patient's pd catheter (not a fresenius product) had migrated out of position and required a surgical revision (performed same day).Additionally, the patient was also diagnosed with "mild" fluid overload and received multiple pd treatments (cycler and manual) with 4.25% dialysate to promote rapid ultrafiltration (uf).The revision was successful, and the patient's dyspnea improved with the additional uf.The patient was discharged on (b)(6) 2021 in stable condition and the patient resumed using the same liberty select cycler as before the events.Per the porn, the fluid overload and patient's complaints of "feeling unwell" are all a byproduct of the pd catheter's poor positioning, and the patient's failure to call the on-call porn when ccpd therapy couldn't be achieved.(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: 17531054
• MDR Text Key: 321134166
• Report Number: MW5137970
• 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: 08/27/2021

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
• Device Catalogue Number: UNKNOWN PD CATHETER
• Patient Sequence Number: 1