MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO CATHETER; PROBE, THERMODILUTION

Model Number PV2015L20-A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Information provided by the customer indicate that the lot number is 662102 or 662103.Described failure could be confirmed during pre-investigation of returned product.Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device evaluation ongoing.

Event Description

It has been reported that on the second day of use, blood flowed backwards to the red connector.The monitor couldn't detect patient temperature since then.There was no harm or clinical consequences to the patient.The catheter has been exchanged.The case was evaluated as reportable as leaking parts in contact with arterial blood pressure have been reported.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The customer provided that the lot number is 662105.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.H3 other text : device evaluation ongoing.

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

The concerned product has been returned by the hospital.In depth investigation of the concerned product revealed a small cut in the blue picco catheter tubing located 18 mm from the channel separation.The separation between thermistor wire and blood lumen was perforated from the same cut.Very likely, this cut in the lumen had led to a blood flow to the thermistor plug and the impossibility of measurement.A 100 % leakage test is performed during production.A dhr check could not identify any non-conformities or deviations relevant to the reported issue.There is no indication for a systematic production or design problem as the complaint rate is very low (< 0,01 %, considering all types of picco catheters).A simulation test by cutting a picco catheter tubing with a scalpel showed a very similar appearance of the cut.This leads to the conclusion that the most likely root cause is seen in an user error by not following the ifu and damaging the picco catheter tubing with a sharp item.The ifu states: "warning: do not alter or cut the catheter, guide wire, or any other set component during insertion, use or removal." the complaint investigation results are supported by the complaint description which says that the leakage has been detected on the second day of use.Overall, investigations did no indicate that the device failed to meet its specification when the event occurred.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The issue will be further monitored on the market to identify trends.

Event Description

Manufacturer reference #: 356630.

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 10475579
• MDR Text Key: 205109834
• Report Number: 3003263092-2020-00012
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 662105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/07/2020; 10/13/2020
• Supplement Dates FDA Received: 09/30/2020; 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 100