FDA Adverse Event
Malfunction
Summary report: N
ACCLAIM STANDARD TUBING DEVICE
MDR report key: 163951
·
Received April 17, 1998
Report
- Report Number
- 2921482-1998-00058
- Event Type
- Malfunction
- Date Received
- April 17, 1998
- Date of Event
- March 1, 1998
- Report Date
- March 30, 1998
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
NON-DELIVERY REPORTED. THE PUMP WAS SET TO INFUSE LIPIDS AT AN UNSPECIFIED RATE OF 8PM PER CUSTOMER ROUTINE. SEVERAL HOURS LATER DURING THE NIGHT SHIFT, THE NURSE NOTED THAT THE LIPIDS BOTTLE WAS STILL FULL. THE DISPLAY HAD INCREMENTED AS IF DELIVERY HAD OCCURRED. THERE WERE NO VISIBLE OCCLUSIONS PRESENT. THE TUBING WAS RE-POSITONED WITHIN THE PUMP AND THE INFUSION WAS RESUMED. DELIVERY THEN OCCURRED AS EXPECTED. NO ADVERSE PT EFFECTS WERE REPORTED. NO ADD'L INFO WAS AVAILABLE. THE SPECIFIC DEVICE INVOLVED IN THE EVENT REMAINED IN USE. THE SERIAL NUMBER WAS NOT RECORDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCLAIM STANDARD TUBING DEVICE | INFUSION PUMP | FRN | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |