MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-22 for HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS manufactured by Hach Company.
[17492149]
Thirty three pts involved. See attached pages 3 & 4. 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. The relevant labs are included on p4, for each pt. 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 anemia. At least one pt was reportedly diagnosed with hemolytic anemia and myocardial infarction. Lot#-7044, expiration date-12/2008. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1048132 |
| MDR Report Key | 1048132 |
| Date Received | 2008-05-22 |
| 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 | 2008-06-12 |
| 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 | 3 |
| 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 | HACH STERICHEK TOTAL CHLORINE REAGENT STRIPS |
| Generic Name | STRIP/TEST/REAGENT/RESIDUAL FOR DIALYSIS |
| Product Code | MSY |
| Date Received | 2008-05-22 |
| Lot Number | 7163 |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1025898 |
| Manufacturer | HACH COMPANY |
| Manufacturer Address | AMES IA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2008-05-22 |