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

Model Number OM-10000Z

Device Problems Positioning Failure (1158); Mechanical Problem (1384)

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

Event Date 06/19/2023

Event Type  malfunction  

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.

Event Description

The hospital reported that during preparation, the acrobat-i stabilizer had looseness of fixed parts (fixing part of the arm is loose).A replacement device was used to complete the procedure.No procedural delay.No harm to patient.

Manufacturer Narrative

Trackwise #(b)(4).Corrected section: h6-medical device ¿ problem code- corrected to "1158".The device was returned to the factory for evaluation on 07/19/2023.An investigation was conducted on 08/01/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the device.A mechanical evaluation was conducted.The positioner was attached and locked onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The flexlink arm was able to be adjusted and positioned, and then locked into place by turning the knob clockwise with no physical or visual difficulties, with the locking lever in both the locked and unlocked positions.Based on the returned condition of the device as well as the evaluation results, the reported failure ¿positioning problem" was not confirmed.The lot # 3000288696 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

N/a.

• 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: 17325904
• MDR Text Key: 319129897
• Report Number: 2242352-2023-00592
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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: 3000288696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1