MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-07-24 for NIPRO SET A209/V803 A209/V808 manufactured by Nipro (thailand) Corp. Ltd..
[321736]
Hemodialysis patient was being connected to dialysis using a catheter access and nipro bloodlines. It was reported that the nurse had difficulty connecting the venous conector (cross-threaded) to the catheter. Nurse disconnected and reconnected without difficulty. Approximately 1 hour into treatment the machine alarmed for low blood pressure. Nurse removed blanket from patient and noted blood on blanket, patient, chair and floor. Approximate blood loss of 500cc. Nurse noted blood seeping from venous connection of bloodline and catheter. Nurse re-secured bloodline to catheter and gave 900 cc of normal saline to patient for fluid replacement. Patient seen by physician, dialysis treatment discontinued, and patient sent to the er for transfusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2003-00001 |
| MDR Report Key | 474130 |
| Report Source | 05,06 |
| Date Received | 2003-07-24 |
| Date of Report | 2003-07-23 |
| Date of Event | 2003-06-28 |
| Date Mfgr Received | 2003-06-30 |
| Date Added to Maude | 2003-07-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CARY GOLDSMITH |
| Manufacturer Street | 3150 NW 107TH AVENUE |
| Manufacturer City | MIAMI FL 33172 |
| Manufacturer Country | US |
| Manufacturer Postal | 33172 |
| Manufacturer Phone | 3055597174 |
| Manufacturer G1 | NOPRO (THAILAND) CORP. LTD. |
| Manufacturer Street | 10/2 MOO 8. BANGNOMKO, SENA |
| Manufacturer City | AYATHAYA 13110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 13110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIPRO SET |
| Generic Name | BLOOD TUBING SET |
| Product Code | FIB |
| Date Received | 2003-07-24 |
| Returned To Mfg | 2003-07-02 |
| Model Number | A209/V803 |
| Catalog Number | A209/V808 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 462976 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA TH 13110 |
| Baseline Brand Name | NIPRO SET |
| Baseline Generic Name | BLOOD TUBING SET |
| Baseline Model No | A209/V803 |
| Baseline Catalog No | A209/V803 |
| Baseline Device Family | BLOOD SET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K010264 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2003-07-24 |