MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS AFU-100 (100...240 V~); PUMPS

Model Number	WB950167
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified emergency procedure, where the peristaltic pump unit afu-100 was used for flushing due to bleeding, the device could not be put into operation leading to a significant prolongation of the procedure and high blood loss of the patient.The intended procedure was completed using a similar device.
Additional Manufacturer Narrative
Additional information: h4 - device manufacturer date; device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in germany (returned to rrc on 2021-03-03).The evaluation could not confirm the reported phenomenon, but the following issues were found: the pump stops after operating for 20 seconds with a setting of 20.The front panel is broken and needs to be replaced.The power switch was stuck and had to be readjusted and a screw from the case was missing which neither impacts the functionality nor the safety of the device.Due to the age of the affected device it is assumed that the stuck switch was caused by mechanical wear and tear.Furthermore, contamination may also have caused the stuck switch.No information was provided on the mechanical damages of the front panel.Damages of this type are usually caused by mechanical force.An improper handling by the user cannot be ruled out.According to the evaluation results, the outage of the pump after the specified time was caused by a defective motherboard and a defective power module.Thus, this event/incident was attributed to component failure.A manufacturing and quality control review was performed for the affected serial number of the "afu-100" without showing any abnormalities.The case will be closed on olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: OLYMPUS AFU-100 (100...240 V~)
• Common Device Name: PUMPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11526212
• Report Number: 9610773-2021-00099
• Device Sequence Number: 17267703
• Product Code: GEI
• UDI-Device Identifier: 04042768501678
• UDI-Public: 04042768501678
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: WB950167
• Device Catalogue Number: WB950167
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1