MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PCA 7.01 W/ MEDNET; PUMP, INFUSION, PCA

Catalog Number 208370401

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return to the manufacturer for investigation; it has not been received.

Event Description

The event involved a report stating that a large amount of air was seen in the iv line of a pca pump and the pump did not alarm.The medication involved in the event was dilaudid.The customer further stated that the documentation on the pump stated that there was 6.3mg of diluadid, when the max amount is 6mg.There was a patient involved, however, there was no serious injury, no adverse event, and no medical intervention required.

Manufacturer Narrative

H10: the device was received by the manufacturer on (b)(6) 2019.The device history was reviewed and found no customer protocol; history was cleared on 10/17/19.There was no protocol recorded in the history log on the event date 09/09/19.During testing, the device was programmed at the following setting: drug concentration: 1 mg/ml, mode: pca only, pca dose: 2 mg, pca lockout: 5 minutes, 4 hours dose limit: 6 mg.After infusing for 3 pca doses, the reading was 6 mg on the pump display.Actual volume measured on the scale (d5547) is 6.0 ml.The error rate was 0.00% (tsm-limit +/- 5%).Device delivered dose properly when patient pendant button is pushed.There is no self-delivery observed during testing.The device also passed pvt delivery accuracy test at 20.15 ml (spec 19 to 21 ml).This device did not have air sensor to detect air in line, therefore air in line will not alarm when air in line is present.The customer complaint for ¿air was in the iv line of the pca and no alarm sounded and the documentation on the pump stated that there was 6.3 mg of bialubib when the max amount is only 6 mg.There was air in the line but the pca is not doing an alarm¿ could not duplicate during testing.Probable cause: no probable cause was found as the device passed delivery accuracy test within the specification.

• Brand Name: PCA 7.01 W/ MEDNET
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9145674
• MDR Text Key: 164342468
• Report Number: 9615050-2019-00420
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Public: ++M3352083704011E$$+721386504/16D20160711
• Combination Product (y/n): N
• PMA/PMN Number: K143612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 208370401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILUADID, UNK MFR; UNSPECIFIED TUBING SET