MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-04 for WALKMED 65 ML RESERVOIR BAG 204820 #IPR-86 manufactured by Walkmed Infusion, Llc.
[71732251]
Explanation for deliquency in 30 day report: in (b)(6) 2017, walkmed infusion, llc transferred ownership and assets to walkmed, llc. Additionally, on (b)(6) 2017, cannon quality group was contracted to assist with the quality management system transition, including management of complaints. At the time this complaint was received on (b)(6) 2017, walkmed had applied for a new emdr account and was waiting for account approval. Due to the transitions and emdr account set up waiting period, walkmed was unable to report this event within 30 days. Upon receiving emdr account approval, reporting this event was an immediate priority and walkmed strived to submit this report in a timely manner. Fda was contacted, regarding the late mdrs and section has been completed per their recommendation. A separate mdr report was generated for the three (3) patients who were using 5fu medication at the time of the events on (b)(6) 2017 and (b)6) 2017. An mdr report was not generated for the pharmacist who discovered the leak during set up, as it was determined that there was no potential exposure to hazardous medication related to that particular event and no indication that there would be potential for serious injury if that particular event were to recur. The actual device was returned to rexmed, not walkmed, on 03/03/2017. Rexmed opened a complaint, #17-003 and investigated the device. Rexmed confirmed a leak in the device luer lock but could not determine a root cause. Nevertheless as a containment action, rexmed is checking that the luer lock has no fissure damage before the reservoir bag has been sent.
Patient Sequence No: 1, Text Type: N, H10
[71732252]
There were 4 individual events involving a leak with 4 different walkmed infusion's ipr bags from lot 20816500 (ref 204820, lot 20816500). Each event involved one person, for a total four (4) people. A total of three patients were exposed to medication during their treatment (on (b)(6) 2017 two patients were affected and on (b)(6) 2017 one patient was affected). Yes 5fu was being administered. The leak was coming from the site between the luer lock and the tubing connected to the ipr bag. Additionally, on (b)(6) 2017 a pharmacist found the leak before given to patient, no 5fu with this one so there was no possible chemical exposure. No injuries to patient or staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723533-2017-00004 |
| MDR Report Key | 6458079 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-04 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-04-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR THOMAS ASSANTE |
| Manufacturer Street | 6555 S KENTON ST SUITE 304 |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 7203514944 |
| Manufacturer G1 | REXMED |
| Manufacturer Street | FRESNEL # 8375 PARQUE INDUSTRIAL BERM |
| Manufacturer City | JUAREZ, CHIHUAHUA 32470 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKMED 65 ML RESERVOIR BAG |
| Generic Name | RESERVOIR BAG |
| Product Code | BTC |
| Date Received | 2017-04-04 |
| Returned To Mfg | 2017-03-03 |
| Model Number | 204820 |
| Catalog Number | #IPR-86 |
| Lot Number | 20816500 |
| Operator | PHARMACIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALKMED INFUSION, LLC |
| Manufacturer Address | 6555 S KENTON ST SUITE 304 SUITE 304 CENTENNIAL CO 80111 US 80111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-04 |