MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

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.The patient had concomitant medication which included an ace inhibitor.The instructions for use provided with this device specify that patients receiving angiotensin converting enzyme (ace) inhibitors as medication can develop, within the first few minutes of a treatment, symptoms similar to acute allergic reactions i.E bronchospasm, edema of airways or larynx, dyspnea, angioedema, urticaria, nausea, vomiting, diarrhea, respiratory arrest, abdominal cramping, hypotension, hypovolemic shock and death.Therefore, special attention ought to be paid to patients receiving ace inhibitors.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within 15 minutes of starting therapy on an m150 circuit, the patient developed hypotension, tachycardia, and started wheezing.The patient was receiving an angiotensin converting enzyme (ace) inhibitor at the time of the event.Treatment was stopped and the blood was not returned.Upon discontinuation of treatment, the patient immediately recovered.Therapy was restarted using a different baxter dialyzer.No additional information is available.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7443372
• MDR Text Key: 105937452
• Report Number: 8010182-2018-00034
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109990
• Device Lot Number: ASKU
• 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: 04/19/2018
• Distributor Facility Aware Date: 03/22/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/19/2018
• Date Manufacturer Received: 03/22/2018
• 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: ACE INHIBITOR
• Patient Outcome(s): Other