MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-16 for DUO FLUID CART ULDU100 manufactured by Dornoch.
[145261472]
(b)(4). The device history record (dhr) for ultra duofluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing. The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed. Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical. On (b)(6) 2019, it was reported from (b)(6) hospital that a duo cart unit was showing the cylinder was full when it was empty. On (b)(6) 2019, drmet biomedical llc was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site and confirmed that fluid was not registering properly in either cylinder of the unit. The technician replaced both level sensors (part #91584 and lot code #0028645) and then verified that the unit was functioning as intended. The technician then returned the unit to service without further incident. The device was tested, inspected, and repaired as per cl? Repair cart rev. 4. Service work order dms-51660-w5m3g3 on 07 may 2019. The root cause for the unit showing incorrect fluid levels was due to malfunctioning level sensors in both cylinders. The level sensor reports fluid levels in the unit; malfunctioning level sensors would result in the incorrect fluid readings reported and could also cause errors to be issued. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after both level sensors were replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
Patient Sequence No: 1, Text Type: N, H10
[145261473]
It was reported that both units on the cylinder show full when it was empty. The event timing was after surgery. There was no patient involvement and no adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001954182-2019-00034 |
| MDR Report Key | 8616121 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-05-07 |
| Device Manufacturer Date | 2011-11-22 |
| Date Added to Maude | 2019-05-16 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | DORNOCH |
| Manufacturer Street | 200 NORTHWEST PARKWAY |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUO FLUID CART |
| Generic Name | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
| Product Code | FLH |
| Date Received | 2019-05-16 |
| Catalog Number | ULDU100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH |
| Manufacturer Address | 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |