MAUDE Adverse Event Report: ZIMMER BIOMET ULTRA EVAC STATION #UL-EV100

Model Number N/A

Device Problems Contamination (1120); Fluid/Blood Leak (1250); Leak/Splash (1354); Split (2537); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation of the event was not complete at the time of this report.A follow up medwatch will be submitted upon completion.

Event Description

It was initially reported that the evacuation unit started leaking.The unit was unplugged and the user facility water supply was shut off.Additional information from the service technician identified that during unit inspection, the tubing on the drain pump was observed to be split and leaking.It was further elaborated that during the service visit, hospital staff reported that the unit leak flooded the decontamination room and leaked through the ceiling which contaminated three suites on the lower floor.The lower floor did not include or rooms.The reported leak was not witnessed by the service technician and only the unit was inspected; the service technician did not investigate the hospital's allegation of flood contamination.The service technician stated that there was a tear in the perastaltic tubing but it was not severe.In addition, the bottom of the unit had only minimal leak evidence but it was not "obvious." the hospital nurse who reported the event was aware of the event but was not involved first hand.The or manager, maintenance manager, risk management, and infection prevention department were all contacted with no additional information available.The director of plant operations and maintenance reported that the facility experienced multiple floods that occurred and these were investigated.This specific event was unable to be identified and no details of the investigation were able to be provided.Should further information be provided, a follow-up medwatch will be submitted.

Manufacturer Narrative

Review of the ultra evac station #ul-ev100, serial number (b)(4), indicated it was installed 20 months ago and has been repaired previously on 10/21/2014.Repair of the unit included replacement of the peristaltic drain pump hose; then tested and it functioned properly.The reported event was confirmed only for the leaking device.The portion of the reported event that the leaking device flooded the decontamination room and it leaked through the ceiling and contaminated three suites on the lower floor was not confirmed.The hospital nurse who reported the event was aware of the event but was not involved first hand.The operating room manager, maintenance manager, risk management, and infection prevention department were all contacted with no additional information available.The (b)(6) reported that the facility experienced multiple floods that occurred and these were investigated.The specific event was unable to be identified and no details of the investigation were able to be provided.The root cause of the reported event could not be specifically determined, but could likely be related to improper use by the customer.If hard or sharp material/debris is processed out of a suction cart and into the evac unit during a cleaning cycle, the drain hose of the evac unit may become damaged and cause it to leak fluid.Please note that the evac unit is meant for processing surgical and bodily fluids only.

• Brand Name: ULTRA EVAC STATION #UL-EV100
• Type of Device: ULTRA EVAC STATION #UL-EV100
• Manufacturer (Section D): ZIMMER BIOMET; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): DORNOCH MEDICAL; 200 nw parkway road; riverside MO 64150
• Manufacturer Contact: kathleen smith ; 200 nw parkway road; riverside, MO 64150 ; 3303438801
• MDR Report Key: 4950772
• MDR Text Key: 23706808
• Report Number: 1954182-2015-00003
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: UL-EV100
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1