ASKU
Report
- Report Number
- 1416980-2026-00048
- Event Type
- Malfunction
- Date Received
- January 3, 2026
- Report Date
- February 13, 2026
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: H6 (UPDATE CODES), H11. H11: THE DEVICES WERE DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
B3/D10: THE EVENTS OCCURRED ON UNSPECIFIED DATES. D1/D4/G4: THE SET IS POTENTIALLY ONE OF THE FOLLOWING: BRAND NAME IS CLEARLINK, MODEL AND CATALOG NUMBER: 2R8486, UDI# IS (B)(4), 510K# IS K161808. BRAND NAME IS CLEARLINK/DUO-VENT, MODEL AND CATALOG NUMBER 2R8480, UDI# IS (B)(4), 510K# IS K153158. E1: INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF UNKNOWN BASIC SOLUTION SETS UNDERINFUSED WHEN USED WITH SPECTRUM INFUSION PUMPS. THE ISSUE WAS DESCRIBED AS, THE DEVICES HAD "TOO MUCH LEFT". THESE OCCURRED DURING THE ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN) VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). TO PREVENT HYPOGLYCEMIA, A DEXTROSE 5% (D5) SOLUTION WAS INFUSED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255800 | ASKU | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORPORATION | ASKU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DEXTROSE 5% (D5)| SINGLE LUMEN PICC| SPECTRUM INFUSION PUMP| TPN |