MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PCA 7.0; PUMP, INFUSION, PCA

Catalog Number 208370401

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The incident involved a pca 7.01 w/ mednet on an unspecified date.Per the report, the wires began smoking after the battery was installed.There was no patient involvement or harm reported.

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If the device is received, a supplemental report will be submitted.

Manufacturer Narrative

The customer reported issue of smoking battery wires was investigated.The device/pump was tested by performing performance verification testing and visual inspection.Melted battery wires were identified.The power supply and wiring harness was replaced and then the device powered on acceptably and performed as expected.Confirmed complaint of melted/smoking battery wires.Probable cause is power supply and wiring harness.Updated information can be found in d4 and h4.D9 - date returned to mfg: (b)(6) 2023.

• Brand Name: PCA 7.0
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18154522
• MDR Text Key: 329610948
• Report Number: 9615050-2023-00643
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Public: ++M3352083704011E$$+721386685/16D20160805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1