MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The previous repair report for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired once, the previous repair being for an issue with the level sensor.The level sensor is associated with the current repair.Thus, this repair was a related issue.On (b)(6) 2018, it was reported from (b)(6) that a unit needed the level sensors replaced.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and evaluated the device and found that both level sensors needed to be replaced.The technician replaced both ring covers and the level sensor inside of cylinder #2, tested the unit, and found the device to be operating within specification.He also found hairline cracks in the top plate, under the cylinder ring, and decided to schedule the unit for exchange.A new cart was shipped from (b)(4) on 16 april 2018, and the replacement cart was noted to be delivered on 17 april 2018.Replite dispatched a service technician to the site to perform the exchange.On 18 april 2018 the service technician confirmed that the exchange was completed and that the exchanged unit was packaged and ready for return.The exchange cart was picked up from the facility on 20 april 2018 and was confirmed that it was returned to (b)(4) on 25 april 2018.The cart was refurbished as noted in a returned equipment log.Service work order (b)(4) on (b)(6) 2018.Although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the level sensors to fail.Therefore, the root cause of the level sensors needing to be replaced cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the unit was in the hallway with a repair tag on it.The event occurred during install/pm/in-service.Follow up stated the unit needed the level sensors replaced.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7552296
• MDR Text Key: 109491613
• Report Number: 0001954182-2018-00032
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500R
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1