MAUDE Adverse Event Report: PERITONEAL DIALYSIS

Device Problem Microbial Contamination of Device (2303)

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Unspecified Infection (1930); Pain (1994); Vomiting (2144); Peritonitis (2252)

Event Type  Injury  

Event Description

Being treated or (during) home dialysis which is called (peritoneal dialysis.) the apparatus pick up bacteria from a piece of plastic on the unit which set up "preventing" infection all over his stomach.Have been doing the peritoneal dialysis.Hence treatment for 2 yrs, when developing stomach pain was treated with antibiotics at the fresenius clinic, shull road.The antibiotics did not help and the infection spread and became worse.The apparatus then quit functioning and while hospitalizing for infection and severe pain was then removed and a new port put in his neck.During a regular dialysis treatment, he went into cardiac arrest, for 35 seconds and was resuscitated and put into (icu) unit spitting up blood and bowel for 2 weeks, difficulty breathing and pain, infections (several)."the pt kind of needed because the infection was peritonitis a fatal infection." he has since been moved to a life crisis care center called (b)(6) hospital and has been there for 2 weeks, and it seems this will be an extended stay.Prayer is needed for recovery.Dr (b)(6) is kidney doctor, (b)(6) is care facility, (b)(6).

• Brand Name: PERITONEAL DIALYSIS
• Type of Device: PERITONEAL DIALYSIS
• MDR Report Key: 6113957
• MDR Text Key: 60474640
• Report Number: MW5066184
• Device Sequence Number: 1
• Product Code: KDJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 87 YR
• Patient Weight: 60