SYNDER HEMOVAC 2545-000-10 SAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1991-12-31 for SYNDER HEMOVAC 2545-000-10 SAME manufactured by Zimmer.

Event Text Entries

[878] A case was performed on patient at 1048. A hemovac was used to facilitate drainage. At 1800 it was noted that there was an absence of drainage in the hemovac. The patient was returned to or at 1915. The hemovac was still not providing suction into the reservoir. A new hemovac was opened in the or and also found to be defective. A third hemovac was opened and utilized without furthur difficultydevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: mechanical problem, telemetry failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device recalled by manufacturer/distributor, device returned to manufacturer/dealer/distributor, device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 335
• MDR Report Key: 335
• Date Received: 1991-12-31
• Date of Report: 1991-12-23
• Date of Event: 1991-12-18
• Date Facility Aware: 1991-12-18
• Report Date: 1991-12-23
• Date Reported to FDA: 1991-12-23
• Date Reported to Mfgr: 1991-12-19
• Date Added to Maude: 1992-04-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYNDER HEMOVAC
• Generic Name: COMPACT EVACUATOR
• Product Code: FHF
• Date Received: 1991-12-31
• Model Number: 2545-000-10
• Catalog Number: SAME
• Lot Number: 910220459
• ID Number: NI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 330
• Manufacturer: ZIMMER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1991-12-31