MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2019, it was reported from (b)(6) hospital that the cart was operating correctly, but had a bad odor even after cleaning.On (b)(6) 2019, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and did not notice signs of odor while the cart was off after a full soak.While testing the unit, the technician noticed that there was a smell as well as low suction coming from the vacuum pump; he determined that the vacuum pump was failing.The technician replaced the vacuum pump (part #91938 and lot code #0027507), installed a new carbon filter (part #ul-cf100 and lot code #0029048) 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.Service work order (b)(4) on (b)(6) 2019.The root cause for the unit having an odor even after cleaning was because of a malfunctioning vacuum pump due overheating.The vacuum pump is responsible for generating the pressure necessary to move liquid through the system during use.If the pump were to overheat during use, the excess heat could cause odors that last even after the unit is cleaned as well as compromise the suction of the vacuum, as experienced in the reported event and during inspection.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the vacuum pump was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

Ultra duo flux cart had a bad odor which continued even after cleaning.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8330984
• MDR Text Key: 136034262
• Report Number: 0001526350-2019-00094
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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