FDA Adverse Event Death Summary report: N

CADD SOLIS VIP PUMPS

MDR report key: 12063540 · Received June 24, 2021

Report

Report Number: 3012307300-2021-06514
Event Type: Death
Date Received: June 24, 2021
Date of Event: June 1, 2021
Report Date: May 26, 2023
Manufacturer: ST PAUL
Product Code: FRN
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

OTHER TEXT: ADDITIONAL INFORMATION. THIS MDR WAS GENERATED UNDER PROTOCOL: (B)(4), AS A RESULT OF WARNING LETTER CMS#: 617147. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE PUMP WAS RUNNING AND INFUSES ACCORDING TO THE RECORDED PARAMETERS. THE COMPLAINT WAS NOT CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED. NO ACTION WAS TAKEN. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. D4: UDI INFORMATION IS UNKNOWN. G5: PREMARKET (510K) NUMBER IS UNKNOWN.

Description of Event or Problem · 1

INFORMATION RECEIVED A SMITHS MEDICAL CADD PUMP WAS BEING IMPLEMENTED ,WHILE A DEATH OCCURRED. THE REPORT WAS GENERATED BY A DOCTOR AND NURSES AFTER FAMILY OF PATIENT HAD PRIVATELY COORDINATED CARE WITH FAMILY DISCUSSING END OF LIFE WISHED FOR THEIR MOTHER (WHO WAS NEARING END OF LIFE) . THE DOCTOR IN TURN CONTACTED POLICE. POLICE ARE REQUESTING THE PUMPS EVENT HISTORY LOG AND REQUISITIONED THE PUMP. REPORTED AN AUTOPSY WILL BE DONE. NO FURTHER INFORMATION ON DRUG INFUSED OR MALFUNCTION IF ANY OCCURRED, VERSES TAMPERING WITH DOSAGES BY USER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
960253	CADD SOLIS VIP PUMPS	PUMP, INFUSION	FRN	ST PAUL

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Death