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

Catalog Number 955467

Device Problem Obstruction of Flow (2423)

Patient Problems High Blood Pressure/ Hypertension (1908); Dizziness (2194); Pallor (2468)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after seven hours of continuous renal replacement therapy with a prismaflex m150 set c, clotting in the filter was observed and a high return pressure alarm was generated.The patient experienced discomfort, further specified as palpitation, dizziness, poor complexion and venous hypertension maintained at 140/80 mmhg.The patient received 200 ml of saline due to suspected hypovolemia.It was reported 2500 units of low-molecular-weight heparin (lmwh) was administered at treatment start, followed by 2500 units of lmwh.The patient reported improvement after receiving the saline.No additional information is available.

Manufacturer Narrative

H10: 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.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 CORPORATION; deerfield IL
• 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 ; 2242702068
• MDR Report Key: 12886956
• MDR Text Key: 283951263
• Report Number: 8010182-2021-00364
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123451
• UDI-Public: (01)07332414123451
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 955467
• Device Lot Number: 21D0302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/05/2022
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female