CASSETTE MEDI RESERVOIR

Report

• Report Number: MW5107248
• Event Type: Malfunction
• Date Received: February 4, 2022
• Date of Event: January 1, 2022
• Report Date: February 2, 2022
• Manufacturer: SMITHS MEDICAL ASD, INC.
• Product Code: LHI
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

PATIENT REPORTED SHE HAD ISSUES WITH 4 CASSETTES OVER THE PAST MONTH. SHE KEPT THE CASSETTES BUT ONLY HAS THE LOT INFORMATION FOR TWO OF THEM: 4203283 AND 4173645. NO OTHER INFO AVAILABLE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE CASSETTE? YES; DID THE PATIENT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO PATIENT/(B)(6) BY PT/CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1373561	CASSETTE MEDI RESERVOIR	SET, I.V. FLUID TRANSFER	LHI	SMITHS MEDICAL ASD, INC.		4173645
1373562	CASSETTE MEDI RESERVOIR	SET, I.V. FLUID TRANSFER	LHI	SMITHS MEDICAL ASD, INC.
1373563	CASSETTE MEDI RESERVOIR	SET, I.V. FLUID TRANSFER	LHI	SMITHS MEDICAL ASD, INC.
1373564	CASSETTE MEDI RESERVOIR	SET, I.V. FLUID TRANSFER	LHI	SMITHS MEDICAL ASD, INC.		4203283

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR	Female

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Infusion or Flow Problem

Type of report · 1

• Initial submission