MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER; STABILIZER, HEART

Model Number ACROBAT-I STABILIZER Z

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise # (b)(4).Event description: the hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer z, arm was not fixed when they turned the handle to fix the om-10000z.They released a new product and continued ope, and ope was completed successfully.This defect had no effect on the patient.The product is from lot 3000140390.The product was used by patients with infectious diseases and could not be recovered.The reported failure couldn't be confirmed as the device could not be returned for evaluation.This issue happened in (b)(6), and it is determined to file a medical device reporting as the similar products are sold in us as well.The investigation has been started, since the complaint was received, and the following contents has been conducted: dhr review: the dhr of the reported lot 3000140390 has been reviewed.No non-conformity is observed indicated the reported failure.All the products had been performed 100% mechanical function test during production.They all passed the function test which demonstrate the knob can be tighten and also can tighten the link arm.Trend review: in the last 12 months, 29th july 2020 to 29th july 2021, the occurrence rate of the knob difficult/ unable to tighten-arm does not lock issue is approx.0.044%.There¿s no similar complaint reported for this reported lot 3000140390.Device could not be returned for analysis, since the device was used by patients with infectious diseases and could not be recovered.Root cause evaluation, as the device could not be returned for evaluation, the reported failure knob difficult/ unable to tighten-arm does not lock couldn't be confirmed and the root cause couldn't be confirmed.Complaint historical data has also been reviewed, the failure knob difficult/ unable to tighten-arm does not lock has happened before and has been investigated.The most probable root cause for the "knob difficult/ unable to tighten-arm does not lock" would cause by the acme nut lead in thread broken during rotating the knob, since the broken lead in thread would potential not smoothly engage or even not engage with the acme screw lead in thread during tightening, the knob could not be tighten, and link arm could not be tightened.The acme nut lead in thread broken could be that rotating the knob anti-clockwise rapidly for several circles and then rotating the knob clockwise rapidly, or rotating the knob leaner or too much strength used, which cause acme screw misaligned with the acme nut lead in thread, acme nut lead in thread broken.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer z arm was not fixed when they turned the handle to fix the om-10000z.They released a new product and continued ope, and ope was completed successfully.This defect had no effect on the patient.

• Brand Name: ACROBAT-I STABILIZER
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: dorota wolpiuk ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12346581
• MDR Text Key: 267430718
• Report Number: 2242352-2021-00680
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: 00607567100008
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: ACROBAT-I STABILIZER Z
• Device Catalogue Number: C-OM-10000Z
• Device Lot Number: 3000140390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1