MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-04 for SYSMEX COAGULATION ANALYZER CA-1000 B4260-1000 manufactured by Toa Medical Electronics.
[16459]
Customer noted unusually long pt coagulation times with the last few pt samples of a run. These long times were reported and treatment course was altered for two pts. One pt had been scheduled for surgery. However, based on the results of coagulation testing the surgery was cancelled. Another pt was receiving heparin therapy while in icu. Based upon the results of coagulation testing, heparin was discontinued for a short period of time and resumed. The instrument functioned as described in the labeling. However, laboratory personnel did not heed error code messages and reported results inappropriately. After reviewing instrument output it appears the instrument was operating with insufficient reagent due to air bubbles or insufficient reagent volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017272-1996-00003 |
| MDR Report Key | 31484 |
| Date Received | 1996-03-04 |
| Date of Report | 1996-02-28 |
| Date of Event | 1996-02-05 |
| Date Facility Aware | 1996-02-08 |
| Report Date | 1996-02-28 |
| Date Reported to FDA | 1996-02-28 |
| Date Reported to Mfgr | 1996-02-28 |
| Date Added to Maude | 1996-03-29 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | SYSMEX COAGULATION ANALYZER |
| Generic Name | COAGULATION ANALYZER |
| Product Code | KQG |
| Date Received | 1996-03-04 |
| Model Number | CA-1000 |
| Catalog Number | B4260-1000 |
| Lot Number | NA |
| 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 | 32633 |
| Manufacturer | TOA MEDICAL ELECTRONICS |
| Manufacturer Address | 4-4-4 TAKATSUBADAI NISHI-KU, KOBE JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-03-04 |