MAUDE Adverse Event Report: BAXTER DIANEAL PD4 AMBUFLEX THERAPHY; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problem Leak/Splash (1354)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Injury  

Event Description

This report was received from (b)(4) and is a spontaneous report by a nurse from the usa of leak at adaptor and attempted to repair it himself and peritonitis with culture positive for staphylococcus in a female patient (born in 1956) coincident with dianeal pd4 ambuflex therapy.On an unreported date, the patient began treatment with dianeal pd4 ambuflex therapy ( dose, frequency and lot number not reported) intraperitoneally (ip) for peritoneal dialysis (pd).During a call with baxter customer services, the following was reported.On an unreported date in 2011, a leak at adaptor occurred and the patient attempted to repair himself.On (b)(6) 2011, the patient diagnosed with peritonitis.On an unreported date in 2011, a peritoneal effluent culture was performed with culture positive for staphylococcus.Treatment was not reported.The patient was recovering from the event peritonitis and outcome of the event leak in adaptor was not reported.Dianeal therapy was ongoing.Medical history included end stage renal disease (esrd), hypertension, diabetes, cardiac disease, cardiac failure, and myocardial infarction.Concomitant medications were not reported.Per the nurse, the event peritonitis was not related to dianeal therapy.An opinion of causality for leak at adaptor and attempted to repair it himself was not provided.Patient injury reported: yes medical intervention required: yes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DIANEAL PD4 AMBUFLEX THERAPHY
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17533803
• MDR Text Key: 321152550
• Report Number: MW5140706
• Device Sequence Number: 1
• Product Code: KDJ
• 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: 01/04/2012

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