MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-05-20 for HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS manufactured by Hach Company.
[857167]
In 2008, a facility nurse reviewing routine weekly lab results for the facility's dialysis pts noted a drop in hemoglobin for approx 33 pts. On the same day, another facility staff noted a possible discoloration of the dialysis lines. The facility immediately discontinued all pt treatments and initiated an investigation, which revealed a suspected chlorine break-through in the facility's water purification system. Hach test strips used to detect chlorine had given false negative readings. The facility's investigation revealed three bottles that were not reactive to chlorine. The bottles originated from lot #s 7163 and 7044. We believe 33 pts were admitted to the hosp throughout the last 14 days. Most of whom were reportedly diagnosed with an anemia. At least one pt was reportedly diagnosed with hemolytic anemia and myocardial infarction. Pt expired in 2008. Cause of death: unknown; unrelated to medical device. Lot#-7044, expiration date-12/2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1048123 |
| MDR Report Key | 1048123 |
| Report Source | 99 |
| Date Received | 2008-05-20 |
| Date of Report | 2008-05-14 |
| Date of Event | 2008-04-30 |
| Date Facility Aware | 2008-04-30 |
| Report Date | 2008-05-14 |
| Date Reported to FDA | 2008-05-14 |
| Date Reported to Mfgr | 2008-05-14 |
| Date Added to Maude | 2008-05-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS |
| Generic Name | STRIP/TEST/REAGENT/RESIDUAL FOR DIALYSIS |
| Product Code | MSY |
| Date Received | 2008-05-20 |
| Lot Number | 7163 |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1016726 |
| Manufacturer | HACH COMPANY |
| Manufacturer Address | AMES IA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2008-05-20 |