MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-01-10 for LIFECARE 175 CONTROLLER 11062 manufactured by Abbott Laboratories.
[20469300]
Underdelivery report number 2 of 2 for this device. The device tested fine after the first reported incident, thus it was suspected to be a user issue. The pump was then placed again in home care use infusing a tpn solution of 1250ml over 12 hrs. A flow detector was not in use. The pump was set up and sounded" like it was infusing and the display indicated volumes delivered. The infusion was to run overnight. Upon awakening in the morning, the pt noted that the display indicated the full volume had infused, however, the iv container was still almost full.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921482-1998-00001 |
| MDR Report Key | 143979 |
| Report Source | 05 |
| Date Received | 1998-01-10 |
| Date of Report | 1997-12-10 |
| Date of Event | 1997-11-08 |
| Date Mfgr Received | 1997-12-10 |
| Device Manufacturer Date | 1995-08-01 |
| Date Added to Maude | 1998-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECARE 175 CONTROLLER |
| Generic Name | PUMP CONTROLLER |
| Product Code | LDR |
| Date Received | 1998-01-10 |
| Model Number | NA |
| Catalog Number | 11062 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140407 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 755 JARVIS DR. MORGAN HILL CA 95037 US |
| Baseline Brand Name | LIFECARE 175 CONTROLLER |
| Baseline Generic Name | PUMP CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | 11062 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-10 |