MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 1996-10-04 for LIFECARE 175 CONTROLLER 11062 manufactured by Abbott Laboratories.
[38366]
Overdelivery reported. The pump is in home use infusing over night tpn. The pt has been on home tpn for a long time. He prefers to set the pump to deliver 900 ml, and then when he awakens he programs the final 100 ml at a slower rate to taper down the infusion. He reported that on several occasions, the 1000 ml iv containers have been empty when the pump alarms for dose end at 900 ml. The display indicates 900 ml delivered. The pt did not report any adverse effects from the delivery without his usual taper down practice. He was concerned, however, because "in the past he has had some blood glucose problems when the tpn was stopped without the taper down period. "
Patient Sequence No: 1, Text Type: D, B5
[17638306]
The reported problem could not be duplicated. There is no statistical increase for delivery error for the infusion pump for the last 12 months. There has been one report of code 102 (overdelivery) for the 12 months ending 11/30/96 for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921482-1996-00028 |
| MDR Report Key | 56072 |
| Report Source | 00,05 |
| Date Received | 1996-10-04 |
| Date of Report | 1996-12-18 |
| Date of Event | 1996-09-01 |
| Report Date | 1996-09-03 |
| Date Mfgr Received | 1996-09-03 |
| Device Manufacturer Date | 1995-04-01 |
| Date Added to Maude | 1996-12-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | INFUSION PUMP |
| Product Code | LDR |
| Date Received | 1996-10-04 |
| Returned To Mfg | 1996-12-05 |
| Model Number | NA |
| Catalog Number | 11062 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 56597 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 1212 TERRA BELLA MOUNTAIN VIEW CA 94043 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-04 |