MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-30 for LIFECARE 175 CONTROLLER 11062 manufactured by Random Corp..
[63214]
Overdelivery noted during biomedical engineering testing. The pump was reportedly tested using abbott performance verification procedures. With an expected delivery of 20ml, the device consistently delivered 24-25ml. (specification requires delivery to be 20 +/-2ml). There was no pt involvement, the device was taken from storage and tested prior to pt use.
Patient Sequence No: 1, Text Type: D, B5
[17055711]
Test and investigation could not duplicate the reported problem. The unit was received from the customer with a broken tubing latch. When tested with the broken tubing latch, the device passed performance verification testing and long term tests. The pump was tested again for pvt after replacement of the broken tubing latch. The pump continued to pass testing. The frequency of death or serious injury reports for code 102 (overdelivery) for lifecare 175 products is approximately 0. 00/million sets.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1580411-1997-00002 |
| MDR Report Key | 96254 |
| Report Source | 05,06 |
| Date Received | 1997-05-30 |
| Date of Report | 1997-04-29 |
| Date of Event | 1997-04-29 |
| Date Facility Aware | 1997-04-29 |
| Report Date | 1997-04-29 |
| Date Mfgr Received | 1997-04-29 |
| Device Manufacturer Date | 1994-11-01 |
| Date Added to Maude | 1997-06-09 |
| 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 | 1997-05-30 |
| Model Number | NA |
| Catalog Number | 11062 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 95030 |
| Manufacturer | RANDOM CORP. |
| Manufacturer Address | 551 NORTHLAND BLVD. CINCINNATI OH 45240 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-30 |