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

Catalog Number ULDU500R

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Udi# (b)(4).The reported event for the device, as provided by the customer, was that the unit had cylinder 1 & 2 tandem errors.Dhr review: the device history record (dhr) for ultra duo flex fluid 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.Evaluation of device: on (b)(6) 2019, it was reported from (b)(6) medical center that the unit had cylinder 1 & 2 tandem errors.On 13 august 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site and confirmed that the unit was reporting tandem errors on both cylinders.The technician replaced the level sensors for reach cylinder and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.No repair checklist was required per crm/ service work order (b)(4) on 13 august 2019.Probable/root cause: the root cause for the unit reporting a tandem warning was due to a malfunctioning level sensor.A tandem warning occurs when too much fluid is added to the cylinder, which can be caused by incorrect or no output from a malfunctioning level sensor.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.Result code- errors were confirmed and level sensor was replaced.Product evaluated by external contractor.

Event Description

It was reported that the unit had cylinder 1 & 2 tandem errors.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.Investigation results showed that the level sensor on both cylinders malfunctioned.

• 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: 8911956
• MDR Text Key: 207032424
• Report Number: 0001954182-2019-00051
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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