MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8363
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
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 extension set 0.22 micron downstream high pressure extended life filter would not flow; further described as ¿the filter becomes empty¿.This issue was identified during a patient infusion.The set was being used to administer dae solution (dextose, amino acid, electrolytes) and running the dae at a low rate of 6.9ml/hr.The set was in use with an anti-reflux valve (non-baxter) connected to a 3-way stopcock (non-baxter).After the nurse first encountered that the filter was empty, the extension set was re-primed again with the 3 way stopcock disconnected and the filter was emptied again after five minutes and the set had to be re-primed a second time.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph using the naked eye which revealed that the set belongs to the reported product code.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.By the nature of the sample, no additional tests were performed.The reported condition could not be verified by visual inspection of the photograph.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.
Additional Manufacturer Narrative
H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing; and the device performed according to product specifications.Additional pull test and dimensional test was performed and no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10063430
• Report Number: 1416980-2020-02754
• Device Sequence Number: 17044050
• Product Code: FPA
• UDI-Device Identifier: 00085412013718
• UDI-Public: (01)00085412013718
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020

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 Catalogue Number: 1C8363
• Device Lot Number: DR19D23045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 11/04/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/15/2020; 11/09/2020
• 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: DAE SOLUTION (DEXTOSE, AMINO ACID, ELECTROLYTES)