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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-4030
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  malfunction  
Manufacturer Narrative
(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 for an endoscopic vein harvesting procedure, hemopro2 extension cable connector was sticking on the hemopro 2 extension cable.A replacement device was used to complete the procedure.No patient involvement.
 
Manufacturer Narrative
(b)(4).This is a reusable oem device; therefore, a lot /serial history review was not applicable.A serial/lot number was not provided and the specific product serial/lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The hemopro2 extension cable device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.No defects were observed.A mechanical evaluation was conducted.The device was evaluated for connector function with reference hemopro 2 (lot # 25131866) per instructions for use (ifu).The arrows were lined up on the hemopro 2 and the extention cable; the device connected without incident.The device was disconnected by pulling back on the extension cable at the connector collar; the device disconnected without any difficulties from the reference adaptor.Both connection ends were evaluated 5 times.We were unable to reproduce the reported failure.Based on the returned condition of the device and the results of the investigation the reported failure mode ¿connection; cord; difficult to detach from device/adaptor¿ was not confirmed.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable connector was sticking on the hemopro 2 extension cable.A replacement device was used to complete the procedure.No patient involvement.
 
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Brand Name
HEMOPRO2 EXTENSION CABLE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7627594
MDR Text Key112291085
Report Number2242352-2018-00574
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC-VH-4030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Date Manufacturer Received08/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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