MAUDE Adverse Event Report: MAQUET CV ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-UA-5001

Device Problems Loss of Power (1475); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech stopped working after the crank was turned 2 times.It became stuck in its state, not opening or closing.Two retractor devices had to be used to separate the sternum in order to remove the activator drive and blades.The hospital did not report any patient effects.The product is returning.The activator drive (b)(4) was being used for an off pump cabg case.The surgeon placed the device in the open chest wound.As he attempted to turn the crank, after approximately 2 turns, the activator drive stopped opening.It became stuck in its state, not opening or closing further.They had to use two retractor devices to separate the sternum in order to remove the activator drive and blades.A new activator drive (b)(4) was opened and the one that was not moving was removed.I evaluated the device.I could get the activator drive to open and close with difficulty, it was not easy to turn the crank.The surgeon stated that this problem has happened several times before.The scrub tech and nurse said the device was working prior to giving it to the surgeon, but once in place and resistance put against it is when the problem occurs.I took the device apart and put it back together and it started working easily again.I checked with central processing and the device is not.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.A lot number was not provided and the specific product serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The device was returned to the factory for evaluation.Evidence of clinical use and no evidence of blood were observed.A visual inspection was conducted.No defects or marks on the activator ii drive mechanism were observed.No defects or marks were observed on the drive handle.A mechanical evaluation was conducted.The drive handle was turned to open and close the unit 5 times.No binding was observed.The handle did not lock and could rotate in clockwise and anticlockwise.Based on the results of the evaluation, the reported complaint was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima activator ii reusable drive mech stopped working after the crank was turned 2 times.It became stuck in its state, not opening or closing.Two retractor devices had to be used to separate the sternum in order to remove the activator drive and blades.The hospital did not report any patient effects.The product is returning.The activator drive ua-5001 was being used for an off pump cabg case.The surgeon placed the device in the open chest wound.As he attempted to turn the crank, after approximately 2 turns, the activator drive stopped opening.It became stuck in its state, not opening or closing further.They had to use two retractor devices to separate the sternum in order to remove the activator drive and blades.A new activator drive ua-5001 was opened and the one that was not moving was removed.I evaluated the device.I could get the activator drive to open and close with difficulty, it was not easy to turn the crank.The surgeon stated that this problem has happened several times before.The scrub tech and nurse said the device was working prior to giving it to the surgeon, but once in place and resistance put against it is when the problem occurs.I took the device apart and put it back together and it started working easily again.I checked with central processing and the device is not.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5648641
• MDR Text Key: 45507322
• Report Number: 2242352-2016-00451
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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 Catalogue Number: C-UA-5001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR