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	04/22/2020
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 set would not flow; further described as ¿the filter set 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 a 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.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.It was observed that the reported product code matched the product in the photograph and all components were placed according to specification.Due to the nature of the sample no functional testing could be performed, therefore the reported condition was not verified.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
Additional information was added to d10, h3 and h6.H6: replace 213 with 170 and 67 with 23.H10: the actual sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Components were placed according to specifications; set was measured dimensionally with no issues.Pressure testing was performed and no leaks were noted.A blockage test was performed which observed solvent blockage between the joint tubing and male luer.The reported condition was verified.The cause of the condition was due to the machine during manufacturing.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: 10063139
• Report Number: 1416980-2020-02751
• Device Sequence Number: 3573959
• 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): 08/10/2020

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: 04/22/2020
• Supplement Date Received by Manufacturer: 06/05/2020; 08/05/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/16/2020; 08/10/2020
• 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: 3-WAY STOPCOCK; ANTI-REFLUX VALVE; DAE SOLUTION (UNSPECIFIED)