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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL HEMOVAC AUTOTRANSFUSION SYTEM, 3/16 IN SOF
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ZIMMER SURGICAL HEMOVAC AUTOTRANSFUSION SYTEM, 3/16 IN SOF Back to Search Results
Catalog Number 00-2555-030-05
Device Problems Leak/Splash (1354); Decrease in Pressure (1490); Pressure Problem (3012)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/15/2014
Event Type  Injury  
Event Description
It was reported that during surgery, there was blood leaking from the line, so the zimmer hemovac was used with a plastic bag in order to prevent leaking.There was also reported low negative pressure.The surgery was delayed by 10 minutes and an alternate device was used to complete the procedure.There was pt harm reported; however despite multiple attempts to retrieve add'l info, there were no add'l details received regarding the reported harm to the pt.No further clinical info was received at the time of this report.
 
Manufacturer Narrative
The device was not returned to the mfr at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
 
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Brand Name
HEMOVAC AUTOTRANSFUSION SYTEM, 3/16 IN SOF
Type of Device
HEMOVAC AUTOTRANSFUSION SYTEM, 3/16 IN SOF
Manufacturer (Section D)
ZIMMER SURGICAL
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key4462215
MDR Text Key16308687
Report Number1526350-2015-00012
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00-2555-030-05
Device Lot Number62180280
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/29/2014
Initial Date FDA Received01/27/2015
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
Patient Sequence Number1
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