MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-06-02 for WALKMED manufactured by Walkmed.
[76717150]
On 4/14/2017, medical specialties distributors (msd), an approved service center for walkmed, received a return wm350vl pump device with a label that the device had been exposed to a chemotherapy spill. Walkmed became aware of the incident during a review of msd's service records for the month of (b)(6) 2017, at which time, a complaint was initiated. Walkmed initiated scar 023 to address msd's delay in communicating the event to walkmed. Although the pump itself was returned, the complaint was related to the reservoir bag, per conversation with a nurse at the user facility. The reservoir bag was not returned for evaluation and no information regarding the make, model, or serial number of the bag could be obtained. Reservoir bag not returned
Patient Sequence No: 1, Text Type: N, H10
[76717151]
According to the april service report from medical specialties distributor (msd), msd received a pump unit with an orange note stating: chemotherapy spill on pump and now keeps beeping occlusion when unit is started per contact with the user facility, the event occurred at the patient's home and it would have been a bag leak. They think the patient wasn't exposed because the bag they keep the pump and everything in (described as a fanny pack) may have acted as a barrier, but aren't certain. They also assured that while they have the pump, they haven't been using it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723533-2017-00008 |
| MDR Report Key | 6608481 |
| Report Source | USER FACILITY |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-06-02 |
| 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 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 |
| Generic Name | RESERVOIR BAG |
| Product Code | BTC |
| Date Received | 2017-06-02 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALKMED |
| Manufacturer Address | 6555 S KENTON ST SUITE 304 SUITE 304 CENTENNIAL CO 80111 US 80111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-02 |