IVAC 560 TUBING N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-20 for IVAC 560 TUBING N/A manufactured by Ivac Corporation.

Event Text Entries

[1682] Ivac 560 iv infusion pump in use (staff did not mark which pump was in use), continuously alarming and not delivering amount of solution ordered. Clinical engineering notified tocheck the pump. Biomedical engineer noted that total parenteral nutrition (tpn) solution leaking onto floor. Verified that pump was functioning correctly but that iv tubing had a hole in it below the clear plastic connector. Iv therapist verified that tubing had been hanging more than 12 hours iv therapist identified that a small rubber disc which normally is in the center of the quarter-size white opaque disc was missing and that hole in tubing haf allowed air to get into line. Tubing was connected to pic line (peripheally-inserted central line) in the patient. No injury to patient. Patient did receive the ordered solution over approx one hour. Tubing has been saved the risk management officedevice 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4110
MDR Report Key4110
Date Received1992-07-20
Date of Report1992-02-17
Date of Event1992-02-05
Date Facility Aware1992-02-05
Report Date1992-02-17
Date Reported to Mfgr1992-02-17
Date Added to Maude1993-05-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIVAC 560 TUBING
Generic NameIVAC IV TUBING
Product CodeFKB
Date Received1992-07-20
Model Number560
Catalog NumberN/A
Lot NumberUNKNOWN
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key3843
ManufacturerIVAC CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-07-20

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