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

Catalog Number 103453

Device Problem Protective Measures Problem (3015)

Patient Problems High Blood Pressure/ Hypertension (1908); Chills (2191)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after treatment with a phoenix dialysis monitor, the patient experienced chills, high systolic blood pressure, a drop-in hemoglobin, a rise in white blood cells (wbc) and a high ldh. It was reported at treatment start, the jugular ¿vascath¿ catheter had to be ¿twisted to make it stand up¿ to be able to work. The intended blood flow rate was 350 ml/min; however, it was reported the rate could not be increased above 250 ml/min. It was reported if the patient coughed or turned their head there was a pressure problem (unspecified). The arterial and venous pressures were reported to be in the range of 70-100 mmhg. It was reported an unknown alarm was generated towards the end of treatment which was overridden ¿several times¿. Treatment was discontinued and while the extracorporeal blood was returning the patient experienced symptoms of chills and high systolic blood pressure. It was reported after treatment ended, following completion of rinse-back, the extracorporeal circuit appeared as if blood had not been returned. A hemastick test was performed and was positive for blood. Labs were performed, and the results showed a drop in hemoglobin from 8. 9 to 6. 6 g/dl, a rise in wbc from 19000 to 53000 and high ldh (no numerical value provided). No medical intervention was provided for the events of chills or high systolic pressure. At the time of this report, the patient outcome was not reported. No additional information is available.

• 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
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8727486
• MDR Text Key: 148970471
• Report Number: 9616240-2019-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/24/2019,07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2019
• Distributor Facility Aware Date: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/24/2019 Patient Sequence Number: 1