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

Catalog Number 107140

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  malfunction  

Manufacturer Narrative

Address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during therapy with two units of prismaflex hf1000 set, air bubbles were observed to be drawn into the extracorporeal (ec) circuit through the ¿free replacement solution tubing after the pod/wheel; fluid present between free bag and pod¿.Air entered the hf1000 filter and treatment was terminated without returning the ec blood to the patient.Air appeared to be coming from a possible damage to the tubing at the pod.A new filter was used and the same issue began almost immediately upon initiation.Blood was not returned to the patient.There was patient involvement but no injury and medical intervention was reported.No additional information is available.

Manufacturer Narrative

Additional information added to d4 lot number and expiration date: the received and correct samples are from batch: 20c0503.H10/h11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The two contaminated devices were received for evaluation.The samples were visually inspected and a pressure test was performed: all the connections were conforming and no leak was observed.The reported air intake was not reproduced.The cause was undetermined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in follow-up mdr #1 is being corrected from blank to 07/21/2021.

• Brand Name: PRISMAFLEX HF1000
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12028584
• MDR Text Key: 259591275
• Report Number: 8010182-2021-00199
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414069254
• UDI-Public: (01)07332414069254
• Combination Product (y/n): Y
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 107140
• Device Lot Number: 20C0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1