MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 04/27/2021

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 at an unknown time during continuous renal replacement therapy using a prismaflex control unit and a prismaflex m150 set, one of the m150 blood lines became disconnected from the bard power trialysis dialysis catheter.This reportedly resulted in "minimal" blood loss.An air detector alarm was generated by the control unit.The nurse immediately clamped the lines, stopped treatment and aspirated air from the lines.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection was performed and did not identify any abnormalities that could have contributed to the reported condition.Pressure testing was performed, and no leaks were noted.The reported condition was not verified.The cause of the condition 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.

Manufacturer Narrative

Lox file was analyzed and no specific issues were identified on the set and on the control unit.The lox file observed that pressure records indicated that a temporary set occlusion occurred during treatment (due to clamp, clot or line being crushed by patient moving) and to confirm that a catheter disconnection occurred, leading to the end of the treatment.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/21/2021.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12032980
• MDR Text Key: 259601335
• Report Number: 8010182-2021-00200
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (y/n): Y
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 109990
• Device Lot Number: 20H1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/01/2021; 09/10/2021
• Supplement Dates FDA Received: 07/23/2021; 07/29/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD POWER TRIALYSIS DIALYSIS CATHETER; PRISMAFLEX MACHINE
• Patient Age: 48 YR