FDA Adverse Event Malfunction Summary report: N

CADD-PCA

MDR report key: 1505 · Received October 8, 1992

Report

Report Number: 33131-1992-00001
Event Type: Malfunction
Date Received: October 8, 1992
Date of Event: September 11, 1992
Report Date: September 14, 1992
Manufacturer: PHARMACIA DELTEC
Product Code: MEA
Product Problem: Yes
Report Source: Distributor report
Reporter Location: TN, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

ON SEPTEMBER 11, 1992 IT WAS REPORTED TO US, R.T. THAT A PATIENT'S MEDICATION VCASSETTE RESERVOIR WAS NOT SECURED TO PHARMACIA DELTEC CADD-PCA. THE SECURING "TAB" ON THE CASSETTE WAS BROKEN. THIS CAUSED ALL THE MEDICATION IN THE RESERVOIR TO INFUSE OVER AN UNKNOWN PERIOD OF TIME.THE CASSETTE CONTAINED APPROXIMATELY 83 ML OF DILAUDID 10MG/ML. WHEN WE WERE NOTIFIED THE PATIENT WAS ROUSABLE AND VITAL SIGNS WERE WITHIN NORMAL LIMITS. IT WAS DETERMINED BY THE PHYSICIAN ON-CALL THAT THE PATIENT WAS NOT HARMEDDEVICE NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). 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	CADD-PCA	N/A	MEA	PHARMACIA DELTEC	5200 PXC	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Other