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

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.

• Brand Name: PRISMAFLEX HF1000
• 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: 10364658
• MDR Text Key: 201609808
• Report Number: 8010182-2020-00115
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107140
• Device Lot Number: 19C2103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 17 YR