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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 Patient Involvement (2645)
Event Date 04/04/2018
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
It was reported post procedure that hemopro2 extension cable would not disconnect from the evh device.The account is reporting after multiple sterilizations the connector begins to stick.No patient involvement.
 
Event Description
It was reported post procedure that hemopro2 extension cable would not disconnect from the evh device.The account is reporting after multiple sterilizations the connector begins to stick.No patient involvement.
 
Manufacturer Narrative
(b)(4).This is a reusable oem device; therefore, a lot history/serial number 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 device was returned to the factory for evaluation.Signs of clinical use was observed.There were no signs of blood detected.A visual inspection was performed.One of the two connectors on the cable was observed to be broken, and missing its outer shell, which would serve for keeping the cord connected to either the hemopro 2 device, or the adaptor.To test the cord's ability to connect and disconnect efficiently, the opposite end of the cord was connected to the hemopro 2 device and then detached.There were no difficulties or struggles in regard to connecting or disconnecting the device.Based on the returned condition of the device, the reported failure "connection issue; cord; break" is confirmed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported post procedure that hemopro2 extension cable would not disconnect from the evh device.The account is reporting after multiple sterilizations the connector begins to stick.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 Key7470578
MDR Text Key106971066
Report Number2242352-2018-00397
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,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
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 Manufacturer05/30/2018
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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