MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2H8864
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
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 two (2) clearlink buretrol solution sets had bubbles accumulated beneath the drip chamber and tube when using the sets.The baxter infusion pump displayed an air alarm while running 10% dextrose.This was noted during product use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : the actual device was not available; however, a photograph of the sample was provided along with two (2) unopened companion samples were received for evaluation.A visual examination of the photograph showed a bubble inside fluid path, additionally, an alarm pump activated.Functional testing was performed on the two companion samples by spiking it into a 1000ml solution bag containing distilled water.During priming, bubbles were observed.Leak/block tests identified a channel leak in the first sample between the drip chamber to the filter.In the second sample a leak was observed between the drip chamber to the burette.Based on the evaluation the channel leak could contribute to an air in the line issue.The reported problem was verified.The cause of the leak between the drip chamber to filter was due to the material during manufacturing process while the cause of leak coming from the drip chamber to burette was not determined.As immediate an action, 100% pressure test (leak test) for the finished good product was implemented.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 BURETROL SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8533591
• Report Number: 1416980-2019-02117
• Device Sequence Number: 1611710
• Product Code: FPA
• UDI-Device Identifier: 00085412071749
• UDI-Public: (01)00085412071749
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K123874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: Other
• Device Catalogue Number: 2H8864
• Device Lot Number: DR18J31021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1