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

Catalog Number ASKU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/25/2019

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 patient who was being treated with continuous renal replacement therapy, crrt, using a prismaflex control unit and a prismaflex filter set experienced blood loss and hypotension.A communication error, code 7 alarm, was reportedly generated causing the prismaflex to enter a patient safe state and resulting in the termination of treatment.Manual blood return was attempted, but the operator accidentally connected the saline bag to the return line and an unspecified volume of blood was entering the saline bag instead of being returned to the patient.The patient reportedly became severely hypotensive, but no information was provided related to medical intervention provided.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, it was reported that the operator accidentally connected the saline bag to the return line which resulted in an unspecified volume of blood entering the saline bag instead of being returned to the patient.There was no allegation of malfunction made against the set.Hence, based on review of clinical circumstances, the event was caused by user error.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISAMFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu
• 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: 8445081
• MDR Text Key: 139599554
• Report Number: 8010182-2019-00079
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 03/22/2019,04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• 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: 03/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Date Manufacturer Received: 04/04/2019
• 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 MACHINE
• Patient Outcome(s): Other