MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number 5C4483

Device Problem Contamination (1120)

Patient Problems Fever (1858); Peritonitis (2252)

Event Date 06/14/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy, and was hospitalized the same day.The peritonitis was manifested by fever.The cause was reported to be due to translocation of bacteria.On an unreported date, the patient began treatment with gentamycin (daily and dose not reported) ip for peritonitis.The patient was discharged from the hospital after three days.The patient had recovered from the peritonitis.Pd therapy was ongoing.Additional information was requested but was not available at this time.This is report 2 of 2 involved in this event.

Manufacturer Narrative

Complaint no: (b)(4).As the sample was not returned, a device analysis cannot be completed.Should additional relevant information become available, a follow up report will be submitted.Same patient as cmplnt-(b)(4).

Manufacturer Narrative

(b)(4).A review of all batch record documents for potentially associated lot number h14a07064 was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.The sample was not returned for evaluation; therefore a device analysis could not be performed.If additional relevant information becomes available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3928508
• MDR Text Key: 4533370
• Report Number: 1416980-2014-22220
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/16/2014
• 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
• Treatment: DIANEAL 1.5% PD2 AMBUFLEX; DIANEAL 2.5% PD4 AMBUFLEX, MINICAP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 MO