ASKU
Report
- Report Number
- 1416980-2026-00049
- Event Type
- Malfunction
- Date Received
- January 3, 2026
- Report Date
- February 12, 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
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.
ADDITIONAL INFORMATION WAS ADDED TO H6. H11: THE DEVICE WAS NOT RETURNED 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.
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF UNKNOWN BASIC SOLUTION SETS UNDERINFUSED WHILE BEING 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 |
|---|---|---|---|---|---|---|---|
| 14257 | ASKU | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORPORATION | ASKU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | D5| SINGLE LUMEN PICC| SPECTRUM INFUSION PUMP| TPN |