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

Device Problems Contamination (1120); Leak/Splash (1354); Device Slipped (1584)

Patient Problems Peritonitis (2252); Test Result (2695)

Event Date 03/12/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The transfer set was loose between the plastic adapter and transfer set which caused a leak and led to peritonitis.The patient was hospitalized for the peritonitis and treated with vancomycin intraperitoneally, zosyn intravenously, and levaquin orally (doses and frequency were unknown).The patient's transfer set was also replaced.The patient was discharged from the hospital and recovered from the peritonitis.Pd therapy was ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).As the device was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become 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
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3774354
• MDR Text Key: 4431578
• Report Number: 1416980-2014-13559
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/02/2014

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: 07/30/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2014
• 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: 1.5% AND 2.5% DIANEAL PD4 AMBUFLEX, EXTRANEAL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR