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

Catalog Number 955467

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems Pain (1994); Malaise (2359)

Event Date 06/10/2023

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter facility name: changyang tujia autonomous county traditional chinese medicine hospital should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported approximately three hours and 25 minutes after starting continuous renal replacement therapy (crrt) using a prismaflex m150 set, the patient complained of pain and discomfort all over the body.Remifentanil was administered intravenously; however, the symptoms were not relieved.One hour later, the patient requested to stop treatment.During the blood return process, the replacement line suddenly disconnected, resulting in the liquid being ¿splashed¿.No blood loss was reported.According to the reporter there was a "damaged cut slice hole problem".No additional information is available.

Manufacturer Narrative

H10: the actual sample was not available; however, a photograph was available evaluation.Visual inspection of the provided photographic sample observed that the replacement line is disconnected from y multi connector.There is no mark of solvent on the tubing and the disconnection is therefore due to absence of solvent.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.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.

• Brand Name: PRISMAFLEX SETS (M)
• 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: 17315497
• MDR Text Key: 319010869
• Report Number: 8010182-2023-00263
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123451
• UDI-Public: (01)07332414123451
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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 Catalogue Number: 955467
• Device Lot Number: 22J0021CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female