MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-13 for INTELLIGENT INFUSOR 2001 UNK manufactured by Mcgaw Medical.
[36019]
Ob pt was started on iv pitocin controlled by iv controller set at 3ml/hr by pt's rn. Ran 16 mins, controller then alarmed "repair 3". Second rn responded by setting controller to "hold" and attended to pt. First rn arrived and noted pitocin infusing at "wide open condition. " unknown amount of medication delivered. Rn clamped line, treated pt with o2, position change and iv flush with lactated ringers solution for uterine tetany and fhr deceleration. Delivered 24 hrs later. No known adverse affect on mother or baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 56856 |
| MDR Report Key | 56856 |
| Date Received | 1996-12-13 |
| Date of Report | 1996-05-24 |
| Date of Event | 1996-05-13 |
| Date Facility Aware | 1996-05-14 |
| Report Date | 1996-05-24 |
| Date Reported to Mfgr | 1996-05-24 |
| Date Added to Maude | 1996-12-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLIGENT INFUSOR |
| Generic Name | INFUSION CONTROLLER |
| Product Code | LDR |
| Date Received | 1996-12-13 |
| Model Number | 2001 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 57373 |
| Manufacturer | MCGAW MEDICAL |
| Manufacturer Address | 1601 WALLACE DRIVE CARROLLTON TX 75006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-12-13 |