FDA Adverse Event Malfunction Summary report: N

SYRINGE DRNIER

MDR report key: 8619 · Received March 17, 1994

Report

Report Number: 35194-1994-09001
Event Type: Malfunction
Date Received: March 17, 1994
Date of Event: February 15, 1994
Manufacturer: GRASEBY MEDICAL, LTD.
Product Code: FRN
Product Problem: Yes
Report Source: Distributor report
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

CLAIMED OVERINFUSION OF PUMP AS FOLLOWS:PUMP SET TO 52MM/DAY45 MINUTES AFTER START OF INFUSION HAD TRAVELLED 8MM SHOULD HAVE TRAVELED APPROX. 1.6MMPUMP HAS BEEN TESTED BY HOSPITAL ELECTRONICS DEPT. AND CAN FIND NO FALT TO EXPLAIN INCIDENT. RETURNED TO MFG FOR FURTHER INVESTIGATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYRINGE DRNIER	INFUSION PUMP	FRN	GRASEBY MEDICAL, LTD.

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other