MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AMC9668

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that the tubing of a continu-flo solution set disconnected from the drip chamber which resulted in a leak of idursulfase.The leak was identified during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Initial reporter last name ¿ (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: the scheduled dose of idursulfase was 24mg in 100ml of saline solution.H4: device manufactured on september 2021.H10: the actual device was not available; however, photographs of the sample was provided for evaluation. visual inspection of the photographs was performed using the naked eye which revealed a detachment at level of drip chamber.The reported condition was verified on the photograph. the cause of the condition could not be determined. additionally, a visual inspection was performed on the retention samples with no issues noted.The retention samples were gravity tested, then leak tested under water via a calibrated provaset with no leak or issues observed.The reported condition was not verified on the retention samples.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: CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14046932
• MDR Text Key: 288829646
• Report Number: 1416980-2022-01648
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765578038
• UDI-Public: (01)05413765578038
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMC9668
• Device Lot Number: 21H11T500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• 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