MAUDE Adverse Event Report: MAQUET SAS SINGLE IV STANDS HOLDER; TUBING, PRESSURE AND ACCESSORIES

Model Number ARD515006999

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.

Event Description

On (b)(6) 2018 getinge became aware of an issue with modutec device.As it was stated, the bars of perfusion arms were descending, what could cause the fusion pumps to fall.There was no injury reported, however we decided to report the issue based on the potential as it may lead to serious injury or worse.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

A correction of describe event or problem section needs to be provided.This is based on the result of an internal review.#d1: previous brand name: modutec.Corrected brand name: single iv stands holder.During the investigation, it has come forward that the device that was involved in the reported event (single iv stands holder), as reported, was in fact never marketed in us and in addition it appears the complaint itself is a duplicate.Therefore, if this information was available since the beginning, we would not have reported the complaint according to 21 cfr 803 as no getinge device is on the us market that is the same or similar.To be entirely transparent we share with you our final evaluation of the case is documented in our complaint handling system as follows; it was established that when the event occurred, the device did not meet its specification and it contributed to event.In the time when the event occurred the device was being used for patient treatment.According to the information provided, the supporting rod detached or slid from the horizontal bar.The detachment of the supporting rod from the horizontal bar is caused by a lack of tightening of the screw fixing the rod on the horizontal bar.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances and the fact that the occurrence rate is considered to be low we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: SINGLE IV STANDS HOLDER
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10815244
• MDR Text Key: 215511702
• Report Number: 9710055-2020-00469
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD515006999
• Device Catalogue Number: ARD515006999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1