MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-11 for SET, EXTENSION BLOODLINE FOR CRRT 36 IN CUSTOM UM-872-36 manufactured by Molded Products, Inc..
[2727067]
Leaking occurred in the new continuous renal replacement therapy (crrt) tubing. The leaking occurred at the connection of the calcium to the venous access line. It is leaking at a permanent connection, not the luer lock. The tubing was saved. The blood was returned and new filter was set up. The tubing began leaking after the patient was repositioned in bed. The practitioner might have been able to only change out the extension tubing rather than the whole set, but decided to change out the entire set. The set was three days old and the tmp(transmembrane pressure) was rising. We are awaiting a response from the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2633354 |
| MDR Report Key | 2633354 |
| Date Received | 2012-06-11 |
| Date of Report | 2012-06-11 |
| Date of Event | 2012-05-07 |
| Report Date | 2012-06-11 |
| Date Reported to FDA | 2012-06-11 |
| Date Added to Maude | 2012-06-28 |
| 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 |
| 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 | SET, EXTENSION BLOODLINE FOR CRRT 36 IN CUSTOM |
| Generic Name | DIALYSIS EQUIPMENT (DESCRIBE BELOW) |
| Product Code | FID |
| Date Received | 2012-06-11 |
| Returned To Mfg | 2012-05-14 |
| Model Number | UM-872-36 |
| Catalog Number | UM-872-36 |
| Lot Number | POTENTIALLY LOT # 80106. |
| ID Number | * |
| Device Availability | R |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLDED PRODUCTS, INC. |
| Manufacturer Address | 1112 CHATBURN AVENUE HARLAN IA 51537 US 51537 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-11 |