MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-09-27 for ABL80 FLEX ANALYZER 393-839 manufactured by Sendx Medical, Inc..
[121914791]
A patient analysis was performed on the subject analyzer, abl80 flex serial number (b)(4), and based on the reported hct/thb result the patient received a blood transfusion. The user was suspicious of the subject analyzer's result and therefore performed another measurement on a comparison abl80 flex that was on-site. Measured results: subject analyzer: thb = 7. 1g/dl hct = 22%. Comparison analyzer: thb = 13. 7 g/dl hct = 42%. Based on a comparison of the results between the subject and comparison analyzers, the user concluded that the subject analyzer results were incorrect and the blood transfusion was unnecessary. A service technician evaluated the analyzer and found that the roller wheel assembly was not working properly. Further investigation revealed the roller wheel assembly housing was cracked around a set screw that is used to secure the roller wheel assembly to the roller motor shaft. The cracked housing resulted in roller wheel assembly slippage affecting sample aspiration and flushing. The issue was resolved following replacement of the roller wheel assembly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027541-2018-00002 |
| MDR Report Key | 7914865 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2006-10-31 |
| Date Added to Maude | 2018-09-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ANGIE HSU |
| Manufacturer Street | 1945 PALOMAR WAY |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7608033481 |
| Manufacturer G1 | SENDX MEDICAL, INC. |
| Manufacturer Street | 1945 PALOMAR WAY |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABL80 FLEX ANALYZER |
| Generic Name | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
| Product Code | JPI |
| Date Received | 2018-09-27 |
| Model Number | 393-839 |
| Catalog Number | 393-839 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENDX MEDICAL, INC. |
| Manufacturer Address | 1945 PALMOAR OAKS WAY CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |