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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (HF); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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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 Key16530306
MDR Text Key311156183
Report Number8010182-2023-00063
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K042938
Number of Events Reported1
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 Number107140
Device Lot Number21K0049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/13/2023
Supplement Dates Manufacturer Received02/15/2023
04/05/2023
Supplement Dates FDA Received03/13/2023
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 Number1
Treatment
JOCATH CATHETER; PRISMAFLEX MACHINE
Patient Outcome(s) Death;
Patient Age13 YR
Patient SexMale
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