MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problem Contamination (1120)

Patient Problems Death (1802); Purulent Discharge (1812); Peritonitis (2252)

Event Type  Death  

Manufacturer Narrative

Complaint no: (b)(4).This report involves a patient who experienced suspected peritonitis in the context of peritoneal dialysis.While there was no definitive peritonitis reported, it is currently unable to be ruled out as a cause for the reported symptoms.The sample was not returned for evaluation and the lot number is unknown, therefore a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a patient experienced suspected peritonitis coincident with peritoneal dialysis (pd) therapy.The peritonitis was manifested by "capd fluid was coming cloudy".The cause of the suspected peritonitis was unknown.It was reported the patient was hospitalized for the event.Treatment was not reported.It was reported the patient's condition was critical; the patient was placed on a ventilator due to "abdominal cause".At the time of this report the patient's fluid was still cloudy and the patient was not recovered from the suspected peritonitis event.The action taken with dianeal therapy was not reported.No additional information is available.

Manufacturer Narrative

(b)(4).It was reported that a patient died coincident with peritoneal dialysis therapy.The cause of death was reported as two unrelated indications.It was not reported if the patient was hospitalized prior to death.It was not reported if an autopsy was performed.It was unable to be confirmed if the patient recovered from the suspected peritonitis event prior to death.It was not reported if therapy was ongoing prior to death or if the patient was performing therapy at the time of death.Additional information was unable to be obtained.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5103698
• MDR Text Key: 26733705
• Report Number: 1416980-2015-37171
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization