MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-11-27 for LIFECARE 175 CONTROLLER 11062 manufactured by Abbott Lab..
[7772846]
The reported problem could not be duplicated. The frequency of death or serious injury for underdelivery complaints for iv controllers is approximately 2. 2/million sets.
Patient Sequence No: 1, Text Type: N, H10
[16365513]
Underdelivery reported, the pump was set to deliver an iron dextran infusion. It was titrated according to the following protocol: initial setting of 50 ml/hr for 15 minutes, then increased to 100 ml/hr for 15 minutes, then to 150 ml/hr for 15 minutes, and finally to 200ml/hr for completion of the 1000ml container. No flow detector was used. An unspecified amount of time after going to 200 ml/hr, a nurse noted that the pump was not delivering even though the display indicated ongoing infusion. There was only approx. 100ml gone from the iv container. The nurse switched pumps and continued the infusion. The pt did not experience any adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921482-1996-00070 |
| MDR Report Key | 53471 |
| Report Source | 05,06 |
| Date Received | 1996-11-27 |
| Date of Report | 1996-12-03 |
| Date of Event | 1996-10-01 |
| Report Date | 1996-10-28 |
| Date Mfgr Received | 1996-10-28 |
| Device Manufacturer Date | 1995-02-01 |
| Date Added to Maude | 1996-12-06 |
| 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 | 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 | 1996-11-27 |
| Returned To Mfg | 1996-11-05 |
| Model Number | NA |
| Catalog Number | 11062 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 54082 |
| Manufacturer | ABBOTT LAB. |
| Manufacturer Address | 1212 TERRA BELLA MOUNTAIN VIEW CA 94043 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-27 |