MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-14 for NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR BL+A209Y/V803 manufactured by Nipro (thailand) Corp. Ltd..
[188104641]
Noted blood leaking on a patient blood tubing set, at the blood pump area, upon inspecting, noted a tear on the blood pump segment of the blood tubing set and blood was leaking, about 250cc total blood loss. Device lot number was not recorded. Notified biomed, he noted that the blood pump rotor was missing the guides for the blood lines and may or may not have caused the tear. Biomed was able to change the malfunctioned part, the treatment was resumed with new lines, the patient was asymptomatic, vital signs were stable, and patient was able to finish treatment without problems, facility administrator and physician was made aware of the event. The patient did return for their next scheduled treatment without issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041145-2019-00019 |
| MDR Report Key | 9714612 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-27 |
| Date Added to Maude | 2020-02-14 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE TEJADA |
| Manufacturer Street | 3150 NW 107 AVENUE |
| Manufacturer City | MIAMI, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 5997174234 |
| Manufacturer G1 | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Street | 10/2 MOO 8, BANGNOMKO, SENA |
| Manufacturer City | AYUTHAYA,?, 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 BLOOD TUBING SET W/TRANSDUCER PROTECTOR |
| Generic Name | BLOODLINES |
| Product Code | FJK |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-01-21 |
| Model Number | BL+A209Y/V803 |
| Catalog Number | BL+A209Y/V803 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO (THAILAND) CORP. LTD. |
| Manufacturer Address | 10/2 MOO 8, BANGNOMKO, SENA AYUTHAYA,?, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |