MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-03 for STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINE manufactured by Hach Company.
[920565]
Machine in use several times. Was cleaned/revised and test for bleach showed. On 7/14 patient condition worsened within 10 minutes of start of dialysis. After rinseback blood line turned light brown. Drain line negative for bleach; blue hanson connector and i pressure bleach. Patient to ed then tcn for dialysis, and overnight stay. Our facility notified of hach reagent strip recall on 7/24 via a renal network. False negatives and positives being found, the report shows. Not clear what cause of patient's change in condition. Reagent strips faulty. However bleach exposure is among the possibilities. Increased length of tubing to rinse also. Dialysis equipment manufacturers notified of incident and responded (fresenius) connector is two step to click/snap. Also, potential for bleach to accumulate during "last pedown".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1153743 |
| MDR Report Key | 1153743 |
| Date Received | 2008-09-03 |
| Date of Report | 2008-09-02 |
| Date of Event | 2008-07-14 |
| Date Added to Maude | 2008-09-12 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINE |
| Generic Name | REAGENT STRIPS |
| Product Code | MSY |
| Date Received | 2008-09-03 |
| Lot Number | 811909 |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1174277 |
| Manufacturer | HACH COMPANY |
| Manufacturer Address | 100 DAYTON RD AMES IA 50010 US |
| Brand Name | ASSOCIATED EQUIPMENT |
| Generic Name | FRESENIUS DIALYSIS EQUIPMENT |
| Product Code | FII |
| Date Received | 2008-09-03 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1174278 |
| Manufacturer | FRESENIUS MEDICAL CARE |
| Manufacturer Address | RENAL THERAPIES GROUP 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-03 |