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

Catalog Number 107140

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/13/2023

Event Type  Death  

Manufacturer Narrative

Initial reporter address (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

In the patient bed and a disconnection between the prismaflex set and a non-baxter jocath catheter was observed.It was further reported the patient experienced desaturation with progressive hypotension, extreme bradycardia, and asystole.Cardiopulmonary resuscitation was started (total 34 min), subsequently the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.After the event, it was found that the return line with an attached 3-step key (3 way stop cock) was disconnected from the patient¿s access, resulting in external blood loss.The amount of blood lost was unknown; however, based on time of disconnection (2-3 minutes and blood flow rate of 260 ml/ min) it was estimated at 520-780ml.No additional information is available.

Manufacturer Narrative

Correction: b5, inadvertently, the first sentence of the previously submitted b5 was missing.B5: it was reported that during continuous renal replacement therapy with a prismaflex hf1000 set, blood in the patient bed and a disconnection between the prismaflex set and a non-baxter jocath catheter was observed.It was further reported the patient experienced desaturation with progressive hypotension, extreme bradycardia, and asystole.Cardiopulmonary resuscitation was started (total 34 min), subsequently the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.After the event, it was found that the return line with an attached 3-step key (3 way stop cock) was disconnected from the patient¿s access, resulting in external blood loss.The amount of blood lost was unknown; however, based on time of disconnection (2-3 minutes and blood flow rate of 260 ml/ min) it was estimated at 520-780ml.No additional information is available.Should additional relevant information become available, a supplemental report will be submitted.

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 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: 16530306
• MDR Text Key: 311156183
• Report Number: 8010182-2023-00063
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

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: 21K0049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 02/15/2023; 04/05/2023
• Supplement Dates FDA Received: 03/13/2023; 04/14/2023
• 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: JOCATH CATHETER; PRISMAFLEX MACHINE
• Patient Outcome(s): Death
• Patient Age: 13 YR
• Patient Sex: Male