MAUDE Adverse Event Report: WORLD OF MEDICINE (W.O.M.) FLUID MANAGER SCALE AND STAND

Model Number 2223.011

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Dispensing (2955)

Patient Problem No Code Available (3191)

Event Date 05/22/2017

Event Type  Injury  

Event Description

Richard wolf medical instruments corporation (rwmic) was notified by facility that at the end of a procedure the amount of fluid dispensed by the manager system (displayed 1600 mls) was different than the fluid amount manually calculated by the staff (3000 mls).Due to the excessive amount of fluid dispensed patient received a foley catheter, stayed in the pacu for longer than normal and most likely required an overnight admission for fluid output management.Two devices work together as one system: id#: 2222.011 - irrigation pump - mdr: 1418479-2017-00010.Id#: 2223.011 - scale/stand - mdr: 1418479-2017-00011.Rwmic received system on 03/17/2008.Facility purchased system on 09/02/2008.System sent to rwmic for repaired/calibrated on 05/10/2011.No similar issues reported in the last three years.Request for additional/missing information has been sent to user facility, no response as of 22jun2017.System (pump & scale) received by rwmic and will be sent to manufacturer ((b)(4)) for investigation.Rwmic considers this matter closed.However, in the event rwmic receives any additional information, rwmic will provide manufacturer of the devices ((b)(4)) with follow-up information.

Manufacturer Narrative

(b)(4).(b)(4) indicated device showed heavy signs of wear and tear.Roller wheels were corroded, holding plates were polluted, saline residue found inside the weighing housing and pole was corroded.(b)(4) performed device history review and found no discrepancies.(b)(4) performed complaint history review and no similar complaint were reported between jul 2006 and aug 2017.(b)(4) indicated device worked according to specification in regards to the deficit measurement, report event could not be confirmed.(b)(4) indicated the most probable cause appeared to be that the deficit had been reset to zero after the fluid bag was changed during the procedure.(b)(4) indicated that according to sticker on the device, it was due for service/calibration apr 2013.Rwmic contacted user facility on four different occasions, once via phone call and three times via emails, in an effort to gather additional/missing report information.No response received as of 10/02/2017.Rwmic considers this matter closed.However, in the event rwmic receives any additional information, rwmic will provide fda with follow-up report.

Event Description

Follow up #1.The following boxes have been completed: date/description of information.Suspect device (due to system requirement on missing data report).Type of report/date sent.Manufacturer narrative.

• Brand Name: FLUID MANAGER SCALE AND STAND
• Type of Device: FLUID MANAGER SCALE AND STAND
• Manufacturer (Section D): WORLD OF MEDICINE (W.O.M.); alte poststrabe 11; ludwigsstadt, 96337 ; GM 96337
• MDR Report Key: 6662264
• MDR Text Key: 78232808
• Report Number: 1418479-2017-00011
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/03/2017,09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2223.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2017
• Distributor Facility Aware Date: 05/24/2017
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention