MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

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 a coronary artery bypass procedure, hst iii system (3. 8mm) broke. The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4). A lot history record review was completed for lots 25153805, 25153936, and 25153948 the last 3 lots shipped to the account prior to the event/aware date. 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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) broke. The hospital did not report any patient effects.

• Brand Name: HST III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: dorota wolpiuk ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 11101885
• Report Number: 2242352-2020-01146
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial