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

Model Number OM-10000Z

Device Problem Mechanical Problem (1384)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure when they opened the pack and checked the acrobat-i stabilizer z flexlink arm was not functioning well.A new device was used.No procedural delay.The product was not used on the patient; no harm to the patient.

Manufacturer Narrative

Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Manufacturer Narrative

Trackwise #(b)(4).Corrected section: g4 date received by mfg (aware date) submitted in initial mdr 2242352-2023-00514 corrected from 03/22/2023 to 06/07/2023.The investigation has been started since the complaint was received, and the following contents have been conducted: 1.Analysis of production: the dhr of the reported lot 3000296552 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 tightened and link arm can be tightened.2.Trend analysis: 22 mar 2022 to 22 mar 2023, the occurrence rate is approx.0.085% which is under anticipate occurrence rate.3.Device was not received for evaluation; the specific root cause for this failure could not be confirmed.4.Review complaint historical data, the failure knob difficult/ unable to tighten-arm does not lock happened before and has been investigated.The most probable root cause for the knob tighten abnormal could be acme nut lead in thread broken for the reason that rotating to lose the knob anti-clockwise rapidly for several circles and then rotating to tighten the knob clockwise rapidly, or rotating the knob leaner or too much strength used, which caused acme screw misaligned with the acme nut lead in thread, acme nut lead in thread broken, then the knob could not be tighten, and link arm could not be tightened.H3 other text : device not received.

• 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: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17247430
• MDR Text Key: 318781644
• Report Number: 2242352-2023-00514
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: 00607567100008
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM-10000Z
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000296552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1