MAUDE Adverse Event Report: AESCULAP AG SUSI TUBING CLAMP 165MM; SUSI SINGLE USE SURGICAL INSTRUMENT

Model Number AN916SU

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: received a complaint about a malfunction of a tubing clamp.According to the costumer, the clamp has not pinched off a tube.The tube in question belongs to a extracorporeal membrane oxygenation device.The instrument is not available for investigation.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.A capa is not necessary.Device not returned.

Event Description

(b)(6).It was reported that the clamp was not properly disconnected, resulting in an pulmonary embolism.This occured during a tube change in the intensive care unit.

• Brand Name: SUSI TUBING CLAMP 165MM
• Type of Device: SUSI SINGLE USE SURGICAL INSTRUMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7492172
• MDR Text Key: 107567819
• Report Number: 9610612-2018-00211
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AN916SU
• Device Catalogue Number: AN916SU
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/23/2018
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other