MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-05 for MEDICAL LABORATORY AUTOMATION MLA ELECTRA 1000C NA manufactured by Medical Laboratory Automation.
[22101]
Lab evaluation showed pro-time greater than 100 secs, fibrinogen 436, platelet count 227, and 3+ serum protein. Diagnosis of coagulopathy made with medical treatment including vitamin k, transfusion with four units of fresh frozen plasma. Labor was induced. Delivery of viable infant. Protime continued at greater than 100 secs. Add'l medical intervention included vitamin k, 8 units of fresh frozen plasma. Pt developed symptoms of pulmonary edema. Medical treatment with lasix, decreased fluids. Pro-time sent to ref lab with results of 7. 4 secs. Pt recovery with home discharge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 38143 |
| MDR Report Key | 38143 |
| Date Received | 1996-09-05 |
| Date of Report | 1996-08-14 |
| Date of Event | 1996-06-07 |
| Date Facility Aware | 1996-06-24 |
| Report Date | 1996-08-14 |
| Date Added to Maude | 1996-09-18 |
| 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 |
| 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 | MEDICAL LABORATORY AUTOMATION |
| Generic Name | COAGULATION ANALYZER |
| Product Code | KQG |
| Date Received | 1996-09-05 |
| Model Number | MLA ELECTRA 1000C |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 39412 |
| Manufacturer | MEDICAL LABORATORY AUTOMATION |
| Manufacturer Address | 270 MARBLE AVE PLEASANTVILLE NY 105702980 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-05 |