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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION
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STRYKER INSTRUMENTS-KALAMAZOO CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN; APPARATUS, AUTOTRANSFUSION Back to Search Results
Catalog Number 0225426000
Device Problem Suction Problem (2170)
Patient Problem Hematoma (1884)
Event Date 02/26/2015
Event Type  Injury  
Event Description
It was reported that during a surgical procedure at the user facility a loss of suction occurred, causing a leak at the wound site.This resulted in medical intervention being needed, additional surgery was required after the patient developed a hematoma.No adverse consequences and no delay were reported with this event.
 
Event Description
It was reported that during a surgical procedure at the user facility a loss of suction occurred, causing a leak at the wound site.This resulted in medical intervention being needed, additional surgery was required after the patient developed a hematoma.No adverse consequences and no delay were reported with this event.
 
Manufacturer Narrative
Evaluation in progress.
 
Manufacturer Narrative
The unit was not available to stryker puerto rico (spr) for evaluation.Therefore, the reported condition cannot be confirmed.
 
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Brand Name
CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4637624
MDR Text Key5578427
Report Number0001811755-2015-01138
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K952224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0225426000
Device Lot Number14276012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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