MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH CATSMART

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Information (3190)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

Over-infusion of heparin.

Event Description

Overinfusion of heparin.Customer reported patient was over heparinized and they are investigating how come.Was this related to catsmart? requesting to have machine looked at by technician.Disposables are still hooked up.Lot number of set is hdt 044.Occurred after cardiopulmonary by pass.Did the event result in delay in beginning or continuing surgical procedure? no.The hospital is investigating an overdose of heparin and they are looking into the catsmart device.No update on patient but the patient is not expired.The tech is in the account servicing the device.Action taken: troubleshot device due to patient being over heparinized.Level detector, all pump rotors, pumps and hct sensor tested and found within factory specifications.Problem: during camera test, found wave forms out of specification.Upon inspection of the camera, found the black camera cover was not in its proper position.Repair: repositioned and secured the black camera cover to its correct position.Tested camera.All camera readings are now within specification.Status: completed maintenance checklist.All tests pass.Ran simulated procedure with no issues.Device has been released for its intended use.Investigation/root cause: the analysis of all received data, especially the device log files, could confirm the description of "black cover was covering some of the camera window." the medical assessment identified that approx.The half of the used heparin was washed out and the other half was transfused to the patient, but the total amount could not be identified due to missing information the root cause for this incident was not clearly identified.The changed position of the black camera cover was confirmed, the following causes were investigated but not confirmed: -improper installation during manufacturing process: the device passed the final endtest, installation and was successfully operated by the customer, therefore implausible (dhr review performed).-device retrofit activity according to service bulletin: there was 6 month interval between retrofit and incident and the device was successfully operated in between, therefore also implausible.A possible cause might have been a slight manipulation of the position of the black bellow during the retrofit activity and a subsequent movement of the bellow over time caused by device operation (vibration).But that scenario could not be confirmed by investigation.No similar complaints have been reported.As a cause, the investigation revealed the improper activities of the operating personnel to have lead to the outcome of the incident: in total, approx.11.000 ml of fluid have been transported to the prc bag (standard bag volume 500ml) by the device.The fluid must have been clearly visible as a heavily diluted solution (water with a light red color) , that has nothing in common with a regular prc concentrate with a high hematocrit that is usually of dark red color and a totally different viscosity.Also, the amount of transferred volume (11000ml vs.500ml bag volume) leads to the assumption that the operator installed a direct connection between the output line of the disposable and the patient, which is not allowed and contradicts the intended use of the cats system.Finally, the operator has the duty to check the autotransfusion product for suitability for retransfusion as required by the device operating instructions.This term was clearly violated in this incident.The investigation could not establish a clear cause for the malfunction of the prc sensor system, therefore no capa measures are possible.As part of an improvement process, the wording in the tsb will be adapted to better describe the removal/installation of the black bellow.Risk assessment: in this case, the patient was transfused a diluted, not correctly washed product.Also, the retransfused volume was higher than the initially collected volume.The issue was initially caused by a defect on the device prc sensor system, but was supported by the operator actions as he did not act according to trained application routines.As also outlined in the op, the operator has to verify the suitability of the product for retransfusion.The risk analysis identifies the hazardous situation "no or incorrect operation of the device", which is rated with a severity of 1 (negligible), caused by "incorrect or inappropriate output or functionality".The overall risk lies within the assumptions of the risk analysis.

• 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 Key: 8637944
• MDR Text Key: 146249307
• Report Number: 3004634229-2019-00001
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K160735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 9005901
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1