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

Catalog Number	1C8687
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 7309499
• Report Number: 1416980-2018-01101
• Device Sequence Number: 1328523
• Product Code: NEP
• UDI-Device Identifier: 00085412068268
• UDI-Public: (01)00085412068268
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2022
• Device Catalogue Number: 1C8687
• Device Lot Number: DR17D05028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIMETHYL SULFOXIDE (DMSO)