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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH CATSMART
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FRESENIUS HEMOCARE GMBH CATSMART Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/09/2020
Event Type  Death  
Event Description
Death of a patient alleged deficiency description: customer was cell saving for a triple a case at 10:00pm, primed machine as usual - started and processed 300ml during case then device started alarming.Received prc failure, saline error, and high voltage error.Checked all clamps and opened lid to make sure no issues, adjusted tubing inside device.Receiving a lot of blood back - stopped and restarted machine for minutes maybe 1-2, 1200+ ml in reservoir.Per email from sr.Cats marketing manager on 7/10/2020: i spoke with (b)(6) (terumo rep) and according to the tech and the chief of perfusion- the perfusion group is not blaming the device for the death as when they went in things were not good and for the most part unrepairable.They do have concerns with the device for the alarms that took place during this time.
 
Event Description
Death of a patient alleged deficiency description: customer was cell saving for a triple a case at 10:00pm, primed machine as usual - started and processed 300ml during case then device started alarming.Received prc failure, saline error, and high voltage error.Checked all clamps and opened lid to make sure no issues, adjusted tubing inside device.Receiving a lot of blood back - stopped and restarted machine for minutes maybe 1-2, 1200+ ml in reservoir.Per email from sr.Cats marketing manager on(b)(6)2020 i spoke with (b)(6) (terumo rep) and according to the tech and the chief of perfusion- the perfusion group is not blaming the device for the death as when they went in things were not good and for the most part unrepairable.They do have concerns with the device for the alarms that took place during this time.The rcc bag is used together with a cuff.The patient is connected directly to the rcc bag.The red cells are returned to the patient by pressure.This is not the intended use.After cell collection the rcc bag must be removed from the system and the red cells must be returned to the patient by gravity.Probable error during this event : · user inflates cuff to return cells to patient · user closes clamp on patient line and forgets to deflate the cuff · device is not able to pump red cells into the bag against the cuff pressure human fault.Result of risk assessment: the issue was causing a possible delay in processing: referring to the risk analysis, the case can be defined by the harm: "insufficient patient care (no or impaired transfusion product)", that is rated with a severity of (b)(4) (negligible).In conjunction with the cso, the complaint was assessed as "no escalation to level 2" after the mdr reportability assessment.
 
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Brand Name
CATSMART
Type of Device
CATSMART
Manufacturer (Section D)
FRESENIUS HEMOCARE GMBH
gruener weg 10
friedberg hessen, D-611 69
GM  D-61169
MDR Report Key10364361
MDR Text Key201600035
Report Number3004634229-2020-00001
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
PMA/PMN Number
K160735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberN/A
Device Catalogue Number9005901
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/10/2020
Event Location Hospital
Date Report to Manufacturer07/10/2020
Date Manufacturer Received07/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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