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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107140
Device Problems Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067)
Event Date 06/26/2020
Event Type  Death  
Manufacturer Narrative
Initial reporter phone no. : (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) treatment with a prismaflex hf1000 set, there was a crack noted the at syringe tubing close to the syringe resulting in a heparin leak. It was reported that approximately 48 hours after initiation of crrt, the heparin syringe was exchanged, after which there was consistent activated clotting time issues, frequent heparin bolus, and increase in heparin infusion rate. One day later, it was observed that "liquid found on syringe arm of prismaflex¿ was coming from a crack at the heparin syringe tubing close to the syringe (green pressure backflow valve) causing the heparin leak. The prismaflex hf1000 set was changed, and blood was not returned to the patient due to high hemoglobin. The treatment was restarted using a new circuit. Seven days later, the patient was taken off dialysis for approximately one and a half hours (reason unknown). It was reported that seven minutes after the new treatment started, the patient became hypotensive and treatment was stopped. Treatment was again restarted approximately two hours later. On the same day, the patient was reported to be fibril and septic (exact times not reported) with acute decompensation during the cause of the day and eventually passed away. The cause of death was not reported. It was not reported if an autopsy was performed. No additional information is available.
 
Manufacturer Narrative
Additional information: the device was received for evaluation. A part of the heparin line with its check valve connected to a syringe was returned for investigation. The lot number of the set could not be verified from the returned sample. Inspection revealed a check-valve to be cracked and leaky. The reported condition was verified. The cause could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
Cracked syringe connection was discovered at approx. 03:00 on (b)(6) 2020. The decreased acts started on (b)(6) 2020. Patient was taken off dialysis at 11:30 on (b)(6). Dialysis was restarted at 13:23. Patient became hypotensive and treatment was stopped a 13:30. Treatment later restarted at 15:30. On (b)(6) 2020, patient condition deteriorated over the course of the day.
 
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Brand NamePRISMAFLEX HF1000
Type of DeviceDIALYZER, 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 Key10364658
MDR Text Key201609808
Report Number8010182-2020-00115
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K042938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number107140
Device Lot Number19C2103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/04/2020 Patient Sequence Number: 1
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