MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8302C

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

Patient Problems Abdominal Pain (1685); Fainting (1847); Peritonitis (2252)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.Should the device be received by baxter for evaluation, a follow-up report will be filed upon completion of an evaluation or if any additional information becomes available.

Event Description

It was reported a pediatric patient experienced bacterial peritonitis coincident with peritoneal dialysis (pd) therapy.The breach in the sterile pathway was further described as "quality defect in cassette"; specifically, fluid leakage from the line that connects the cassette to the patient's transfer set.It was reported the tubing line had a perforation.The event was manifested by fainting and abdominal pain.The same day as onset, the patient was hospitalized for the event.The same day as hospitalization, the patient was treated with vancomycin (dose, frequency and route not reported) and cefepime (dose, frequency and route not reported).At the time of this report, the patient remained hospitalized, antibiotic therapy was ongoing and the patient was recovering from this peritonitis event.Pd therapy was ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).It was reported that on the same day as peritonitis onset, the patient began treatment for the peritonitis with ceftazidime (dose, frequency, and route not reported, previously reported as cefepime).Six days after onset, the patient was recovered from the event and was discharged from the hospital.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; however, the lot number of the device was identified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5447856
• MDR Text Key: 38580128
• Report Number: 1416980-2016-03760
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K012988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 5C8302C
• Device Lot Number: H15F30072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 37