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); Ventricular Tachycardia (2132); No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with a prismaflex m150 set, the patient experienced an unspecified reaction (not further specified).There was no medical intervention reported with the event.No additional information is available.

Manufacturer Narrative

Additional information: five days prior to receipt of the initial report, the patient was initiated on continuous renal replacement therapy (crrt) using acba citrate for regional citrate anticoagulation.Immediately following start of treatment, the patient presented with v-tachycardia and drop in blood pressure (bp), (no numerical data provided).Treatment was interrupted and the extracorporeal blood was returned to the patient.The patient was treated with amiodarone and epi drip to increase the bp.A new treatment attempt was made later the same day; however, systolic bp dropped to 60s within five minutes and treatment was once again terminated with blood return.No pretreatment bp values were reported.Epinephrine dosage was increased and an unspecified vasopressor was prescribed.Three days later, a third attempt to initiate crrt in hemofiltration (cvvh) mode was made, this time without using citrate as anticoagulant.Prismasol was used as both pre-and post-replacement solution and the patient fluid removal rate was set to 200 ml/h.Hydrocortisone was administered intravenously during the treatment.No further patient or treatment related data was provided and it is not known for how long the patient was treated with the 3rd prismaflex m100 filter set.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 8152699
• MDR Text Key: 129972820
• Report Number: 8010182-2018-00166
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2018,01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2018
• Distributor Facility Aware Date: 11/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/07/2019
• 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: PRISMAFLEX PUMP
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 99