MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK TRANSFER SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 1C8687

Device Problems Degraded (1153); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified number of clearlink blood bag spike adapters were leaking.The adapters leak when they are used to push the reagent, dimethyl sulfoxide (dmso).It was reported that the plastic housing surrounding the rubber port of the set deteriorate/breaks apart after the dmso is pushed through which results in leaks.The reporter advised that they do not use the blood bag spike adapter for iv access within their facility.Their operations staff uses the adapter to make a cryopreservation media for their stem cell products and the dmso protects the cells during the freezing process.So, the staff had been transferring the dmso from its original container to another bag to store the cryoprotectant.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed the plastic housing which surrounds the rubber port of the set was deteriorated.The reported condition was 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.

• Brand Name: CLEARLINK TRANSFER SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7309499
• MDR Text Key: 101376166
• Report Number: 1416980-2018-01101
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412068268
• UDI-Public: (01)00085412068268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2022
• Device Catalogue Number: 1C8687
• Device Lot Number: DR17D05028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIMETHYL SULFOXIDE (DMSO)