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

Catalog Number 114093

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within the first few minutes of therapeutic plasma exchange with a prismaflex tpe2000, a blood leak detector alarm was triggered and an internal blood leak was identified.Visible blood tinged effluent was observed in the effluent line and the drain bag.Visible blood was also observed on the outside of the filter semi-permeable membrane fibers.Treatment was stopped without blood return.A total of 125ml of blood was lost.The patient was stable and the vital signs were normal.Within twenty (20) minutes of starting a new tpe treatment the patient became pale and presented with weakness, nausea and vomiting.The blood pressure reading was 84/43 mmhg.The patient was treated with an unspecified amount of saline.The patient reported they were not feeling well and treatment was interrupted with blood return and another 30 ml saline was provided.The patient 's condition subsequently improved, and the blood pressure increased to 110/60 mmhg.Tpe treatment was suspended for the day.No additional information is available.

Manufacturer Narrative

H10: the actual device was received for investigation.A pressure test was performed, no bubbling, no leak or entry of air was observed.The reported condition was not verified.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.

Manufacturer Narrative

Additional information added to b1, h1 and h10.H10: based on additional information from device evaluation, and review of clinical circumstances surrounding the event, it is possible that the event of patient symptoms requiring medical intervention was associated with the previous blood loss in combination with underlying medical condition and applied treatment parameters when restarting the tpe treatment, therefore, it is unlikely that the prismaflex tpe 2000 caused or contributed to the serious event of patient symptoms.Based on additional information received, prismaflex tpe 2000 was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX TPE
• 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 ; 2242702068
• MDR Report Key: 13970927
• MDR Text Key: 288786129
• Report Number: 8010182-2022-00085
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414111038
• UDI-Public: (01)07332414111038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PMA P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 114093
• Device Lot Number: 21D1404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 04/25/2022; 07/13/2022
• Supplement Dates FDA Received: 04/26/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NI.
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Male