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

Catalog Number AMC9668

Device Problem Component Misassembled (4004)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that the clamp of continu-flo solution set was in opposite way.It was further reported that this was "preventing coupling with the pump and could not start infusion since the unspecified pump displaced occlusion".This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Correction h10.H10: correction to e1: initial reporter phone no.: (b)(6).H4: device manufacture date: unspecified date in september 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed which revealed an incorrect assembly issue.The reported condition was verified.The cause of condition was due to a manual assembly issue during the manufacturing process.A nonconformance has been opened to address this 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: 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: 14084461
• MDR Text Key: 289078187
• Report Number: 1416980-2022-01728
• 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: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• 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: 21I04T695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• 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