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

Device Problems Contamination (1120); Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

Patient Problem Peritonitis (2252)

Event Date 07/12/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis event was reported to be disconnection of the transfer set.The patient was hospitalized the day before being diagnosed.The treatment for the peritonitis included injection (inj) of ceftazidime (1 gram, frequency and route not reported), inj of amikacin (125 mg, frequency and route not reported), inj of vancomycin (500 mg, frequency and route not reported) and inj of heparin (5000 iu, frequency and route not reported).Outcome of peritonitis was not reported.The action taken with dianeal therapy was not reported.Additional information was requested, but is not available at this time.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number was unknown; therefore, a device analysis could not be completed.If additional relevant information is obtained, then a follow-up mdr 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3984991
• MDR Text Key: 15123315
• Report Number: 1416980-2014-25496
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2014

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2014
• Initial Date FDA Received: 08/06/2014
• 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
• Treatment: DIANEAL 1.5% ULTRABAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR