FDA Adverse Event Malfunction Summary report: N

SPECTRUM INFUSION PUMP

MDR report key: 9767443 · Received February 27, 2020

Report

Report Number: 1314492-2020-00504
Event Type: Malfunction
Date Received: February 27, 2020
Date of Event: February 4, 2020
Report Date: March 10, 2020
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: FRN
PMA / PMN Number: K133801
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE CATALOGUE# IS 35700BAX2. PMA/510K# K133801. ADDITIONAL INFORMATION B5: IT WAS REPORTED THAT TWO UNSPECIFIED SPECTRUM PUMPS ALARMED UPSTREAM OCCLUSION DURING HEPARIN THERAPY (DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION H10: THE DEVICES WERE NOT RETURNED AND THE SERIAL NUMBERS ARE UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN UNSPECIFIED SPECTRUM PUMP ALARMED UPSTREAM OCCLUSION DURING HEPARIN THERAPY (DOSE, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
229673	SPECTRUM INFUSION PUMP	INFUSION PUMP	FRN	BAXTER HEALTHCARE CORPORATION	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1