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

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support to request assistance with canceling treatment on the liberty select cycler due to a "medical emergency." during follow-up with the patient's pd registered nurse (porn), it was clarified that the patient's catheter extension was pulled out.The patient did not complete treatment on the cycler on the day of the event.The porn stated that the patient came to the clinic the following day and the catheter extension was able to be corrected at the clinic.The patient was prescribed prophylactic antibiotics (vancomycin (1.5 grams, intraperitoneal, one day) per physician's order.A culture was also taken, the results of which were negative for infection.The porn confirmed the patient continues pd therapy without issue.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further investigation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17523424
• MDR Text Key: 321102249
• Report Number: MW5130372
• 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: 08/12/2021

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
• Patient Sequence Number: 1