MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; PROBE, THERMODILUTION

Catalog Number PV2014L22-A

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested.The involved product was returned for investigation and investigation is ongoing.No similar complaints have been received within the last three years.A supplemental medwatch report will be sent when the investigation is completed.(b)(4).

Event Description

During initial complaint investigation it was detected that the tip of catheter was partially clamped in on area of the sealed seam: the sealed seam of the sterile packaging had a width of 3,5 mm instead of 6 mm (required according din en iso 868-5).No harm or clinical consequences were reported.Mfg ref- (b)(4).

Manufacturer Narrative

The complaint has been further investigated.A review of the dhr did not reveal any non-conformities relevant to the reported issue.A complaint review over the last 3,5 years did not reveal a similar complaint.It is considered as likely that the tubing of the catheter moved in the tray during the sealing process which let to the deformation of the tip and incomplete seal.On the basis of the investigation results it can be concluded that systemic root causes as a weakness of the design or an systemic issue during the manufacturing process are considered as unlikely.The most probable root cause is seen in an individual error during production in combination with the inadequately performed visual inspection in this case.As conclusion this event of (b)(4) is seen as an isolated issue.This kind of issue will be monitored on the market.Please note, getinge usa sales, llc(importer) is submitting the report on behalf of pulsion medical systems se (exemption number e2018007).Contact: (b)(6) 45 barbour pond road wayne, new jersey 07470.

Event Description

Mfg ref: (b)(4).

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen
• MDR Report Key: 8556095
• MDR Text Key: 146360343
• Report Number: 3003263092-2019-00005
• 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
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: PV2014L22-A
• Device Lot Number: 619521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 120