MAUDE Adverse Event Report: HELENA LU MAQUET; TUBING, PRESSURE AND ACCESSORIES

Model Number MODUTEC

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

After receiving this complaint, a maquet surgical workflows account manager spoke with customer, it's confirmed that: hospital staff normally transfer the iv pole to the m-shift trolley without any issue in the past.Hospital staff was trained , but have no training records.Maquet suzhou conducted following initial investigation after receiving the complaint.This concerned m-shift clamp was delivered in apr-y2017.Dhr and relevant record of this concerned m-shift clamp were reviewed, no any deviation was identified from the manufacturing process and final release testing.Complaint historic data about this concerned m-shift clamp were reviewed.There was no any feedback received during installation and after released to end user until dec-2018.Complaint historic data was also reviewed for any similar case reported in the past.Around (b)(4) units m-shift clamp have been configurated with csus and delivered since year 2015.Till now no similar case was reported.Maquet suzhou has sent an new m-shift clamp to customer for replacement, and is requesting the defectives sample back for further investigation.A follow-up report will be submitted when it is done.(b)(4).

Event Description

On (b)(6) 2018, hospital staff told maquet us when transfer the iv pole from ceiling supply unit to the m-shift trolley, as m-shift clamp did not engage onto the trolley, the iv pole and locking mechanism fell to the floor.No person was hit.No injury or death was reported.Manufacturer reference: (b)(4).

Event Description

Manufacturer reference: (b)(4).

Manufacturer Narrative

Maquet suzhou did further investigation based on the returned defective sample.Here is the investigation summary: historic data review: this concerned m-shift clamp was delivered in apr-y2017.Dhr and relevant record of this concerned m-shift clamp were reviewed, no any deviation was identified from the manufacturing process and final release testing.Complaint historic data about this concerned m-shift clamp were reviewed.There was no any feedback received during installation and after released to end user until dec-2018.Complaint historic data was also reviewed for any similar case reported in the past.Around (b)(4) units m-shift clamp have been configurated with csus and delivered since year 2015.Till now no similar case was reported.Returned defective sample analysis: a visual inspection was performed on the returned m-shift, the product was verified in a good condition, no obvious defect was observed.The function/performance of the returned sample was verified according to m-shift infusion column and clamp assembly(document no.Mp-csu-0148),the test result showed the clamp is in good condition.Ifu review summary: the maximum load of m-shift is 50 kg (110ibs), overloading may damage the system or cause other unexpected accident.Before rotating the handle, make sure the docking pole is completely inserted into the clamp in the proper position.With these information, it could be concluded that this problem is very likely caused by unintended use, the device is verified with functions as intended.This is the only case reported so far, it¿s believed as an isolated case.No further action is to be taken except keeping monitoring on the feedback from field.

• Brand Name: MAQUET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• MDR Report Key: 8191636
• MDR Text Key: 131491080
• Report Number: 3007417753-2018-00001
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUTEC
• Device Catalogue Number: SU8907040009
• Device Lot Number: 7010004530
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1