MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Improper or Incorrect Procedure or Method (2017)

Patient Problem Peritonitis (2252)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A pediatric peritoneal dialysis (pd) patient damaged the pd tubing which caused a leak and resulted in peritonitis.The cause of the issue was further described as the patient, who is a toddler, bit into the pd tubing which caused the leak and resulted in peritonitis (no further detail was provided).The patient was hospitalized for three days due to the event and received unspecified treatment.No further information was provided regarding the outcome of the peritonitis event.It was not reported if pd therapy was ongoing.No additional information is available.

Manufacturer Narrative

Concomitant medical products: dianeal pd2 1.5% and 2.5% were specified to dianeal pd2 ambuflex (1.5% and 2.5%).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

As the sample 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: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6343063
• MDR Text Key: 67800846
• Report Number: 1416980-2017-01404
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

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?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2017; 04/20/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: DIANEAL PD2 1.5%; DIANEAL PD2 2.5%; HOMECHOICE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 YR