MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 103453

Device Problem Imprecision (1307)

Patient Problems Chest Pain (1776); Dyspnea (1816); Blood Loss (2597)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a phoenix machine.Did not detect air bubbles during patient treatment.The patient presented with cough, thoracic pain and shortness of breath.The patient was in pain for five minutes and was treated by administering oxygen.It was reported that the patient was walking without assistance after treatment and no hospitalization was required.No additional information is available.

Manufacturer Narrative

The device was evaluated on site by a qualified technician.Visual inspection found the patient sensor was out of calibration range.The reported condition was verified.A functional check was performed and the patient sensor was calibrated and cleaned.An electrostatic discharge test was performed and passed.The abd (air bubble detector) sensor device was received for evaluation.Visual inspection observed that the abd had increased sensitivity.The cause of the condition was not determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• MDR Report Key: 8346612
• MDR Text Key: 136494546
• Report Number: 9616240-2019-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K103832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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: Health Professional
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/17/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 47