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

Catalog Number 107140

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Loss of consciousness (2418)

Event Date 06/22/2022

Event Type  Death  

Manufacturer Narrative

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.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using an unspecified prismaflex set and an unspecified baxter crrt machine, a line became disconnected.It was alleged there was failure to adequately secure the patients lines.The patient reportedly developed an air embolism and lost consciousness.It was alleged the crrt machine failed to shut down to protect the patient from the embolism.The reporter stated every effort was made to aid in the patient¿s recovery.Eight days later, the patient reportedly died due to hypoxic ischemic brain injury.Attempts are ongoing to obtain the device history logs, serial number and device for further evaluation.No further information was available at the time of this report.

Manufacturer Narrative

Additional information added to b5, b7, d1, d4, d10, g4, h6 and h10.B5: upon follow up it was reported the event occurred while using a prismax machine and a prismaflex hf1000 set (previously reported as unknown).The access catheter line disconnected from the port when the patient was getting ready to attend a physical therapy session.At the time of the event, the patient had been in the hospital for 3-4 weeks to recover from another indication.D1: brand name: prismaflex sets (hf) d4: catalogue #: 107140; d4: lot #: 21k0109; d10: concomitant product: prismax machine; g4: pma/510k #: k042938.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 SETS (HF)
• 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 60073 ; 2242702068
• MDR Report Key: 16980360
• MDR Text Key: 315736975
• Report Number: 8010182-2023-00169
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107140
• Device Lot Number: 21K0109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/24/2023
• 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: PRISMAX MACHINE; UNSPECIFIED CRRT MACHINE
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Male