MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem Blood Loss (2597)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This event was filed through the fda's medwatch program under report mw5072033.The product will not be returned to zimmer biomet for investigation.The investigation is in progress, once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that neither of the cylinder could read any volume during case.The event occurred during surgery and the intellicart was inaccurately measuring fluid suctioned from patient.The patient required an extra unit of blood during surgery.The patient was placed in recovery and monitored closely for any other adverse events and there were none.No other adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: date of report, suspect medical device info., device available for evaluation?, date received by mfr, type of reports, if follow up, what type?, device evaluated by mfr, evaluation codes, additional mfr narrative.The previous repair report for intellicart fluid system 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 a monitor issue on (b)(6) 2017.The monitor was not associated with the current repair, so the previous repair was a non-related issue.On (b)(6) 2017, it was reported by valley hospital medical center that the unit was not reading the fluid level in the cylinder and also added that the unit was reading negative fluid level.An exchange for the new cart was scheduled.A new cart (b)(4) was shipped from (b)(6) to the facility (shipping #(b)(4).On (b)(6) 2017, the new cart was confirmed to have been delivered to the facility and service company was dispatched a service technician to the site to perform exchange.On (b)(6) 2017, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The technician then repackaged the old cart so that it returned.The exchanged cart was picked up from the facility.The exchange cart was confirmed to have been returned to (b)(6) (shipping# (b)(4) on (b)(6) 2017 and it was refurbished without further evaluation as noted in the zpm 13.0139 a return equipment log.Service work order (b)(4) on (b)(6) 2017.The service technician was unable to verify the reported issue.Therefore, based on the information provided, a specific root cause of the reported event 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.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• 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: 6939650
• MDR Text Key: 89234840
• Report Number: 0001954182-2017-00032
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00514010100
• Device Lot Number: 0024178
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention